|Year : 2017 | Volume
| Issue : 3 | Page : 235-245
Antihyperlipidemic activity of Navaka Guggulu prepared with fresh (Naveena) and old (Purana) Guggulu: A randomized clinical trial
Kruti Yagneshkumar Vyas1, Prashant Bedarkar2, R Galib3, Pradeep Kumar Prajapati3
1 Department of Rasa Shastra and Bhaishajya Kalpana, Shri O H Nazar Ayurveda Mahavidhyalaya, Surat, India
2 Department of Rasa Shastra and Bhaishajya Kalpana, Institute of Post Graduate Teaching and Research in Ayurveda, Gujarat Ayurved University, Jamnagar, India
3 Department of Rasa Shastra and Bhaishajya Kalpana, All India Institute of Ayurveda, New Delhi, India
|Date of Web Publication||19-May-2017|
Kruti Yagneshkumar Vyas
Lecturer, Department of Rasashastra and Bhaishajya Kalpana, Shri O H Nazar Ayurved Mahavidhyalaya, Surat, Gujarat
Source of Support: None, Conflict of Interest: None
Introduction: Navaka Guggulu is a well-known polyherbal formulation containing Guggulu (Commiphora wightii Arn. Bhandari) as main ingredient. It is effectively used in Medoroga (hyperlipidemia), Sthaulya (obesity), and other Kaphaja roga. In classics, fresh (Naveena) Guggulu is attributed with Brimhana (body mass increasing) effect while old (Purana) with Atilekhana (scrapping). Earlier studies reported that 1-year-old Guggulu possesses better effect on body weight, body mass index, and cardinal symptoms of Medoroga along with significant lipid lowering effect against fresh Guggulu. It infers that old sample of Guggulu is beneficial. Aim: Considering the results of 1-year-old sample, an attempt has been made to evaluate comparative antihyperlipidemic effect of Navaka Guggulu prepared by old (3-year-old-Purana) Guggulu and fresh (Naveena) Guggulu. Materials and Methods: Navaka Guggulu was prepared by freshly collected and 3-year-old samples of Guggulu. Patients who satisfied inclusion criteria of hyperlipidemia were randomly allocated into two groups, namely, A and B and Navaka Guggulu was administrated at a dose of 2 g twice daily with lukewarm water during Prabhata and Nishi kala (1 h before meal) for 8 weeks. Results: Navaka Guggulu prepared from 3-year-old sample exhibited better results in reducing serum cholesterol (8.94%), serum triglycerides (22.76%), and very low-density lipoprotein (VLDL) level (23.10%), wherein Navaka Guggulu prepared from Naveena sample, reduction was found 4.58% in serum cholesterol, 17.26% in serum triglycerides, and 17.76% in VLDL level. Conclusion: Navaka Guggulu prepared from 3-year-old (Purana) sample is better antihyperlipidemic agent against fresh (Naveena) sample.
Keywords: Commiphora wightii, fresh Guggulu, Guggulsterone, Guggulu, hyperlipidemia, Navaka Guggulu, old Guggulu
|How to cite this article:|
Vyas KY, Bedarkar P, Galib R, Prajapati PK. Antihyperlipidemic activity of Navaka Guggulu prepared with fresh (Naveena) and old (Purana) Guggulu: A randomized clinical trial. Med J DY Patil Univ 2017;10:235-45
|How to cite this URL:|
Vyas KY, Bedarkar P, Galib R, Prajapati PK. Antihyperlipidemic activity of Navaka Guggulu prepared with fresh (Naveena) and old (Purana) Guggulu: A randomized clinical trial. Med J DY Patil Univ [serial online] 2017 [cited 2017 May 26];10:235-45. Available from: http://www.mjdrdypu.org/text.asp?2017/10/3/235/206589
| Introduction|| |
Navaka Guggulu is a well-known polyherbal formulation containing Guggulu (Commiphora wightii Arn. Bhandari) as the main ingredient. It is indicated in Medoroga (hyperlipidemia), Sthaulya (obesity), and other Kaphaja roga (diseases due to Kapha) by all seers. The same formulation is named as Vyoshadi Guggulu,Dashanga Guggulu, and Trayushnadi Guggulu in different classics. This formulation is reported for its antiobesity activity., It has also been studied along with other drugs in hyperlipidemia.,
Different forms of Guggulu are in use in for various purposes since Vedas. It is a well-known drug in Ayurveda emphasized with qualities such as Ruksha (dry), Laghupaki (light in digestion), Sara (spreading), Rasayana (rejuvenator), Swarya (improves voice), Deepana (appetizer), Medohara (decreases Medodhatu), Mehahara (antidiabetic), Vatahara (pacifies Vata), etc. In addition to this, details on different types of Guggulu with their respective therapeutic attributes have also been comprehensively explained in ayurvedic classics. Bhavamishra categorized into two types of Guggulu, namely, Purana (old) and Naveena (fresh). “Purana Guggulu” has been attributed with “Atilekhana” (scrapping) properties in comparison to Naveena Guggulu.
From the time when Guggulu fraction (Guggulsterones) were found and proved for their antihyperlipidemic activity, multiple experimental, and clinical trials have been started on Guggulu and its sterones. Even anti-inflammatory, antimicrobial, antiarthritic, cardioprotective, antioxidant, etc., activities of Guggulu were proven. Looking into the effectiveness, a standardized ethyl acetate extract of Guggulu was developed and released by the Central Drug Research Institute, Lucknow, under the brand name Gugulipid in 1987.
In earlier reported study, old Guggulu stored for 1 year showed better effect on body weight, body mass index (BMI), and cardinal symptoms along with significant lipid lowering effect against fresh Guggulu. As time duration for Purantva of Guggulu is not specified in any classical text, 1-year-old Guggulu is taken as Purana Guggulu possibly; this duration may not be sufficient to provide better antihyperlipidemic activity. Looking into this, a sample that is stored for 3 years is considered as Purana. Considering practical difficulties in preparing pills out of Gomutra shodhita Guggulu,Navaka Guggulu is prepared in this study as it is well-known formulation mentioned for Medoroga chikitsa. Considering all these, attempts were made to evaluate comparative antihyperlipidemic activity of Navaka Guggulu prepared with fresh (Naveena) and 3-year-old (Purana) samples.
| Materials and Methods|| |
Collection of raw materials
Guggulu from naturally cultivated plant at Dwaraka Forest Range, Gujarat, was collected from Gujarat State Forest Development Corp. Ltd., Vadodara, during February 2011 (Batch No. B 005, Code-148600). This sample was preserved for 3 years in polyethylene bags at room temperature (28°C–32°C) to make it old. Another sample of fresh Guggulu was collected in the same manner during February 2014 (Batch No. B 003, Code-153700). Fresh Gomutra is collected from the local market of Jamnagar.
Other raw drug materials were collected from the Pharmacy, Gujarat Ayurved University, Jamnagar [Table 1]. All ingredients were authenticated in the Pharmacognosy Laboratory, Gujarat Ayurved University, Jamnagar, for their genuinity.
Methods of preparation of Navaka Guggulu
Navaka Guggulu was prepared in five batches from each fresh and old samples by following classical guidelines. Physical impurities were manually removed from raw Guggulu, and Shodhana was done by Swedana (boiling) in Gomutra (cow's urine). For Shodhana procedure, one part of Guggulu gum was made into small pieces and added with four parts of fresh cow's urine. After complete dissolution of Guggulu by heating at 75°C–80°C temperature, the contents were filtered through cotton cloth. The filtrate was reboiled to evaporate water content and solidify Guggulu. After obtaining semisolid consistency, Guggulu was dried in oven at 50°C. Other plant ingredients enlisted in [Table 1] were individually powdered (80#) and mixed in equal amounts. This blend was mixed in increments with equal parts of Shodhita Guggulu, and homogenous mass was made. Pills were prepared from this mass using the pill cutting machine and dried in oven at 40°C. Navaka Guggulu prepared using Shodhita Naveena Guggulu sample is coded as NNGV, and Navaka Guggulu prepared using Shodhita Purana Guggulu sample coded as PNGV.
Selection of patients
The study was conducted at Jamnagar. The study was started after obtaining approval from the Institutional Ethics Committee (PGT/7-A/Ethics/2013-2014/2753/2.14, dated-09/12/2013) and registered at Clinical Trial Registry of India, ICMR, New Delhi (CTRI/2014/07/004798).
Patients of either sex aged 20–60 years with increased level of any of serum lipids such as serum cholesterol (>200 mg/dL), serum triglycerides (>150 mg/dL), serum low-density lipoprotein (LDL) (>130 mg/dL), serum very low density lipoprotein (VLDL) (>40 mg/dL) were included in the study.
Patients associated with any concomitant serious disorders involving liver, kidneys, heart, lungs, and other organs, persons undergoing treatment for any other serious illness, gravid women and lactating mothers were also excluded from the study.
The study was randomized, double-blind study. Computer generated randomization sequence was followed for random allocation of patients and the ones satisfying the inclusion criteria were grouped into two groups, namely, A and B. Navaka Guggulu was administrated in the dose of 2 g twice a day with lukewarm water during Prabhata and Nishi kala (1 h before meal) for 8 weeks. After completion of study, data were collected and analyzed statistically.
Routine hematological parameters including total leukocyte count, red blood cell, hemoglobin, white blood cell, erythrocyte sedimentation rate, and urine examinations were carried out in all patients to assess the condition of disease and to exclude any underlying pathology. Biochemical investigations such as lipid profile, blood urea, random blood sugar, serum creatinine, serum glutamic oxaloacetic transaminase, serum glutamic pyruvic transaminase, and alkaline phosphatase were also carried out before and after the treatment.
Classical signs and symptoms of Medoroga such as Kshudra Shwasa (exertional dyspnea), Trisha (thirst), Nidradhikya (increased sleep/drowsiness), Sada (fatigue), Kshudha Adhikya (increased appetite), Swedadhikya (increased perspiration), and Daurgandhya (offensive body odor) were taken as subjective criteria. Multidimensional scoring pattern [Table 2] was adopted to assess the response of trial drugs objectively and for statistical analysis. This score was obtained before and after the treatment, and percent relief was calculated to assess the efficacy of therapy. Biochemical investigations (serum cholesterol, serum triglyceride, high-density lipoprotein [HDL], LDL, and VLDL) body weight and BMI were considered as objective criteria and analyzed before and after the treatment.
The data obtained in clinical study was subjected to statistical tests and calculated on the basis of percentage of improvement in each parameter in all the treated groups. Statistical tests were performed by using SigmaStat 3.1 Software (Systate Software Inc, San Jose, California) and GraphPad Prism 6 Software (Graphapad software Inc, La Jolla, CA 92037 USA).
The data are expressed as mean ± standard error of mean for both groups. Paired “t” test was applied to evaluate the effect of therapy on hematological, biochemical investigation, weight, and BMI between groups at P< 0.05. Wilcoxon signed-rank test was applied to evaluate the effect of therapy in individual group for subjective criteria to determine significance between groups at P< 0.05. Coefficient variant (CV) was applied to the statistical data for evaluating the better group of therapy in lipid profile, weight, and BMI.
| Observations|| |
Maximum numbers of patients (37.04%) were from the age group of 51–60 years, female (56.79%), married (96.30%), and Hindu (93.83%) by religion. Maximum patients were having Kapha Vata Prakriti (37.03%) Madhyama Sara (77.77%), Madhyama Satva (45.67%), Madhyama Samhanana (76.54%). Sama Pramana (100%), Madhyama Satmya (37.03%), Avara Vyayama Shakti (54.32%), Madyama Abhyavarana Shakti (82.71%), Madhyama Jarana Shakti (74.07%), Mandagni (40.74%), and Madhyama Koshta (54.32%) were found in maximum patients.
The dominance of Madhura (sweet) and Katu (pungent) Rasa (59.30%) in diet was found maximum. Diet dominant in Guru (heavy) (62.96%) and Snigdha (unctuous) Guna (61.73%) and Adhyashana (56.79%) was found in majority of enrolled. Consumption of irregularly hotel food (77.78%) and use of cottonseed oil in daily food consumption (62.96%) was found maximum. Divaswapa (day sleep) was found in 60.49%, while Avyayama (no exercise) in 88.89%.
Maximum patients developed the symptoms in less than a year (77.78%), and a negative family history of hyperlipidemia was found in 91.36%. Maximum patients were habitual to sedentary lifestyle (53.08%). Maximum patients showed symptoms of fatigue (85.18%), exertional dyspnea (59.25%), increased perspiration (55.55%), and thirst (50.61%). Increase (Vridhdhi) of Kapha Dosha was found in 97.53% and Mansa Dhatu in 62.96%. Vitiated (Dusht) Medo Dhatu was found in 97.53%. Maximum patients (49.38%) were over weighted. In 55.55% patient, normal serum cholesterol level was found, while borderline elevation of serum triglycerides was found in 43.20%, normal LDL level in 67.90%, and normal VLDL in 70.07%.
| Results|| |
After completion of the study, data were collected and analyzed statistically. After this, blinding of the groups was revealed, accordingly it was found that patients of Group A were administered with PNGV while the patients of Group B with NNGV.
The study was carried out in 81 registered patients of hyperlipidemia. Out of which, 73 completed the course of treatment and 8 were dropped out. Totally, 40 patients were registered in Group A, among them, 37 patients completed the treatment whereas out of 41 registered patients, 36 patients have completed the treatment in Group B [Figure 1].
Both the drugs provided highly significant decrease (P < 0.001) in exertional dyspnea and fatigue, with more percentage of decrease in Group B. Group A showed significant decrease (P < 0.05) in thirst, increased sleep, and increased perspiration whereas Group B showed significant decrease (P < 0.05) only in thirst and insignificant (P > 0.05) decrease in increased sleep and increased perspiration. Insignificant raise (P > 0.05) was found in increased appetite in Group A; whereas no change was found in Group B. Insignificant decrease (P > 0.05) was found in bad odor with Group A [Table 3].
Group A exhibited better results in reducing serum cholesterol (8.94%), serum triglycerides (22.76%), and VLDL levels (23.10%), whereas in Group B, 4.58% reduction was found in serum cholesterol, 17.26% in serum triglycerides, and 17.76% in VLDL levels. Group A showed highly significant decrease (P < 0.001) in serum cholesterol and significant decrease (P < 0.05) in serum triglycerides and VLDL levels, whereas in Group B, significantly decrease (P < 0.05) in serum triglycerides and VLDL was found. Administration of Group A showed statistically significant (P < 0.05) decrease on body weight and BMI also [Table 4] and [Table 5].
|Table 4: Effect of therapy on lipid profile, body mass index, and body weight|
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It was observed that with the treatment of Group A, 43.24% of the patients had complete remission, 18.91% mild improvement, 2.7% marked improvement, while 21.62% of patients were unchanged and 13.51% patients' condition was worsened. In Group B, 36.11% of patients had complete remission, 16.67% showed mild improvement, 13.89% showed marked improvement while 25% were unchanged and in 8.33% patients, the symptoms were exacerbated [Figure 2].
The comparative effect in between the groups on chief complaints and lipid profile was analyzed and found that Group A is better in reducing thirst, increased sleep, and increased perspiration while exertional dyspnea and fatigue were better managed with Group B. Group A showed better effect to reduce serum cholesterol, serum triglyceride, LDL, and VLDL. Serum HDL was found reduced in both groups, but percentage decrease was found more in Group B. Here, the results are presented on the bases of CV [Table 6].
|Table 6: Effect of test drugs Group A on chief complaints and lipid profile in comparison to Group B (results based on coefficient variant)|
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| Discussion|| |
Both groups found to be effective in providing relief in subjective criteria. In Medorogi persons, obstruction of Vata by Medo Dhatu causes symptoms such as fatigue, exertional dyspnea, thirst, increased sleep, and increased perspiration, etc.Navaka Guggulu contains drugs having properties such as hot, pungent, and scrapping in majority. The digestive (Ama Pachana), appetitive, scrapping, lightness increaser, Vata-kapha palliative properties of these drugs help in the reduction of above symptoms. Thus, it eradicates Medoja obstruction by scrapping activity and normalize Vata. Reduction in exertional dyspnea and fatigue can also be attributed to the loss of body weight caused by the administration of Guggulu. In comparison between the groups, Group A showed the significant effect to reduce symptoms, which may be due to old sample of Guggulu that is accredited with great scrapping (Atilekhaniya) property than fresh Guggulu. Appetite was found insignificantly increased in Group A inferring appetizer property Guggulu.
It is also evident from test results that both of the drugs have significant antihyperlipidemic effect. VLDL transports endogenous triglycerides whereas LDL transports cholesterol and phospholipids to peripheral cells. Reduction of levels in triglycerides are consistent with reduction in VLDL (similar percent reduction of both markers in either groups), this suggests probable transport of endogenous triglycerides by VLDL to peripheral tissues may be one among antihyperlipidemic mechanisms of either test drugs. There is comparatively less reduction in serum Cholesterol as well as serum LDL as that of percentage reduction in triglyceride and VLDL. Almost similar percentage reduction in both the markers is observed. This may justify the reduction of serum triglyceride as transportation to peripheral tissues by LDL for utilization. There has been observed comparatively more percentage reduction in the level of VLDL than that of reduction in the level of LDL in both the test drug-administered groups; this suggests that both of the drugs probably enhanced catabolism of VLDL as LDL is an end product of VLDL. LDL considered as better prognostic marker in ischemic heart disease, peripheral vascular diseases, atherosclerosis, and cerebrovascular episodes than VLDL. cholesterol/HDL ratio  is prognostic marker in ischemic heart diseases and monitoring criteria of treatment of hyperlipoproteinemia. The treatment is targeted to lower cholesterol/HDL ratio. This ratio was decreased from 3.569 to 3.409 in Group A and remained unaltered in Group B [Table 7] which shows comparatively better efficacy of Group A.
The present clinical study revealed no statistical significant difference in providing relief in between the two drugs. In spite of decrease in total proteins in Group A, albumin/globulin ratio is in normal range (<1.5). Other markers of hepatic function are also within physiological range. These observations rule out the possibility of hepatic dysfunction. This suggests that both the drugs do not alter physiological processes of liver function, kidney function, hematopoietic system, functioning of bone marrow, reticuloendothelial tissue, etc., Whereas reduction in raised lipid levels which is evident in the current study is desirable pharmacological action of both the test drugs. Reduction in total protein does not reflect serious disruption of physiological activity as level of serum albumin which is synthesized in liver is maintained, and albumin/globulin ratio is also maintained within physiological limits. Reduction of total proteins in Group A is clinically insignificant and does not reflects increased catabolism, as end product of protein metabolism, i.e., blood urea  is within the normal range in this group. Comparatively more reduction in hyperlipidemia was also seen with Group A. Hence, there is likely the possibility that proteins are utilized for formation of lipoproteins.
It is noteworthy that, in spite of the increase in appetite or remaining it unaltered in Groups A and B, respectively, there was reduction in various types of hyperlipidemia, as well as there was reduction in body weight in both the treatment drug administered groups. This can favor the hypothesis that both drugs have certainly catabolized endogenous fat and mobilized deposited fat from storage sites may or may not be along with reduction in absorption from gut. It can be again hypothesized that both of the test drugs have reduced absorption of fats/lipids from gut as there is comparatively more reduction in the level of serum triglycerides. Glycerides, sterols such as serum triglycerides, serum cholesterol, are simple lipids. After entering into systemic circulation, simple lipids on complexation with other molecules turn to complex lipids such as lipoproteins, glycolipids, etc. Thus, hypertriglyceride levels are affected first and in more intensity with ingestion of lipids than other LDL, VLDL, and HDL. Besides antihyperlipidemic effect and lack of adverse alteration in any other physiological marker, both of the drugs have been shown to improve quality of life by reducing all symptoms which are commonly associated with hyperlipidemia, however, works to correlate their association is need of an hour, which is beyond scope of the present research work.
On comparison, both groups showed antihyperlipidemic effect. Guggulsterone-E and Z are claimed as bioactive compounds of Guggulu which shows antihyperlipidemic effect. In analytical study, both groups found to contain Guggulsterone-E and Z. However, effect in lowering serum cholesterol, serum triglyceride, and VLDL found more in Group A. It may be due to percentage variation of Guggulsterones in groups which was found in high-performance liquid chromatography study. Effect on lipids found more may be due to more concentration of Guggulsterone-E in Group A. There was no significant decrease found in LDL in both groups. This is because 67.90% registered patients were having LDL in normal level.
No strict dietary restrictions as well as lifestyle changes were given to patients. The difference in the results obtained is attributed to the pharmacological efficacy of the drug.
Body weight and BMI reduce significantly in both groups, which show Navaka Guggulu has antiobesity (Sthaulyahara) effect. Group A showed better effect than Group B, which indicates dry and great scrapping property of old Guggulu.
In overall effect of therapy, unchanged result was seen in 21.67% of Group A and 25% in Group B. In addition, worsen result was found in 13.51% in Group A and 8.33% in Group B. This may due to patients were not advised to change their lifestyle and dietary routine to check effect of drug alone. Diet and lifestyle factors have direct impact on lipids. Significantly reduced serum lipid values and the risk for atherosclerosis and its clinical squeals through lifestyle modification consisting of diet and exercise was earlier reported.
Both the drugs seem to be working on primary hyperlipidemia. Among them, Group A has a better antihyperlipidemic effect than B as it improves the quality of life too. Test drug administered in Group A should be preferred clinically than that of test drug administered in Group B. Safety of both the drugs can be further extrapolated by property of drugs to unaffected nutritional demand of body responsible for maintenance of health while reducing excess and unwanted body weight and hyperlipidemia.
Reduction of 5.76% in serum cholesterol, 17.17% in serum triglycerides, and 18.36% in VLDL with fresh sample of Guggulu and reduction of 2.53% in serum cholesterol, 13.64% in serum triglycerides and 11.07% in VLDL with old sample was reported earlier. In comparison to this, PNGV exhibits more percentage relief on serum lipid levels while no difference found with NNGV sample result. This infers that storage of Guggulu for longer period yield in more lekhana properties.
Probable mode of action
The combination of pungent taste; light and dry properties; Ushna Veerya and Katu-Vipaka dominant drugs in Navaka Guggulu, having all the properties to break down pathogenesis of hyperlipidemia. These qualities are beneficial in lowering the lipid profile in the registered patients [Table 8].
The Ingredients Of Both The Test Drugs Probably Have Either Synergistic Action Or The Process Of Compound Formulation Imparts Synergism In The Formulations Administered In Both The Groups. As The Therapeutic Dose Of Guggulu As Well As Ingredients Of The Formulations When Used Individually Are Far Higher Than Those Were Administered In The Present Clinical Trial. This Supports The Therapeutic Claims Of Guggulu Mentioned Very Frequently In Ayurvedic Classics And Establishes Guggulu As Distinguished Therapeutic Entity Apart From Simple Binding Agent. Among Peculiarities Of Guggulu Kalpana One May Be Postulated As Its Role In The Enhancement Of Bioavailability Of Other Ingredients Of Guggulu Kalpana (Present In Similar Formulation) Through Gastrointestinal Retention By Gastroretentive Drug Delivery System, Which May Be Due To Sustained Release Of Medicaments Of Powdered Ingredients And Concentrated Liquids, Increase Contact With Epithelial Surfaces, Prolonging Residence Time In Stomach, Delaying Intestinal Transit, Enabling Stabilization Of Drug Against Hydrolysis, Oxidation, Reduction, Chemical Change Etc., Judicious Synergetic Combinations.
With judicious admixture of gums of natural origin along with medicaments, it is possible to develop delivery units with balance properties so that adhesion, density, hydration, drug release rate, etc., can be tailored to drug in question and physiological characteristics of the target delivery site.
Shodhana in Gomutra also imparts better scrapping activity (Lekhana) by virtue of its pungent and bitter taste; sharp and light properties, Ushna Veerya and Katu Vipaka. Other drugs such as Triphala,Pippali,Shunthi,Musta,Chitraka, and Vidanga have also proven lipid lowering activity. Thus, the whole composition exhibited antihyperlipidemic effect. Old Guggulu was appreciated with great scrapping property which can be seen by reduction in lipid levels, body weight, and BMI in comparison to fresh Guggulu in this study.
| Conclusion|| |
Navaka Guggulu formulation poses antihyperlipidemic activity and also beneficial in weight reduction. Use of 3-year-old Guggulu can give better effect in comparison to freshly collected Guggulu.
Financial supportand sponsorship
This study was supported by Institute for Post Graduate Teaching and Research in Ayurveda, Gujarat Ayurved University.
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8]