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CTRI Number  CTRI/2014/06/004702 [Registered on: 24/06/2014] Trial Registered Retrospectively
Last Modified On: 29/09/2015
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Management of Lipid disorder with Ayurveda 
Scientific Title of Study   A Comparative clinical study of Gomutra Haritaki with and without Langhana and Pachana in the management of Dyslipidemia. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shivam Joshi 
Designation  PhD Scholar 
Affiliation  Institute for Post Graduation Teaching and Research in Ayurveda 
Address  OPD 21 OPD Building Department of Kayachikitsa IPGT&RA Gujarat Ayurved University Jamnagar
Institute for Post Graduation Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India 
Phone  9427230432  
Fax    
Email  ayu_holistichealth@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Mandip Goyal 
Designation  Assistant Professor 
Affiliation  Institute for Post Graduation Teaching and Research in Ayurveda 
Address  Department of Kayachikitsa 4th floor New Building IPGT&RA Gujrat Ayurved University Jamnagar
Department of Kayachikitsa 4th floor New Building IPGT&RA Gujrat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India 
Phone  9427572306  
Fax    
Email  kaurmandip22@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Shivam Joshi 
Designation  PhD Scholar 
Affiliation  Institute for Post Graduation Teaching and Research in Ayurveda 
Address  OPD 21 Department of Kayachikitsa IPGT&RA Gujarat Ayurved University Jamnagar
Institute for Post Graduation Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India 
Phone  9427230432  
Fax    
Email  ayu_holistichealth@yahoo.co.in  
 
Source of Monetary or Material Support  
Institute For Post Graduate Teaching and Research in Ayurveda 
 
Primary Sponsor  
Name  Institute For Post Graduate Teaching and Research in Ayurveda 
Address  Institute For Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar 361008 Gujarat India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Shivam Joshi  Institute for Postgraduate teaching and Research in Ayurveda  OPD 21 PG Ayurveda Hospital Institute for Postgraduate teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT 		 9427230432

ayu_holistichealth@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Dyslipidemia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Gomutra Haritaki with Langhana and Pachana   Langhana and Pachana for 2 weeks Langhana (4 days) Pachana (10 days) Dhanyaka and Sunthi sidhha jala twice a day morning and evening Gomutra Haritaki 2 tab. (500 mg) TDS with luke warm water before food for 8 weeks 
Comparator Agent  Gomutra Haritaki without Langhana and Pachana  Placebo (starch capsule 2 capsule twice a day morning and evening) for 2 weeks Gomutra Haritaki 2 tab.(500 mg)TDS with luke warm water before food for 8 weeks 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Elevated levels of Serum cholesterol {201mg/dl or more} and/or
Elevated S.triglycerides {151mg/dl or more} and/or
Elevated S.LDL {131mg/dl or more} and/or
Elevated S.VLDL {41mg/dl or more}
 
 
ExclusionCriteria 
Details  Age below 25 and above 60 years
Drug induced hyperlipidemia
Systemic illness like TB, CA, Advanced stage of DM and endocrine disorders.
CNS disorder e.g.encephalopathy
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Weight Reduction
Lightness of Body 		 Weight Reduction
Lightness of Body 
 
Secondary Outcome  
Outcome  TimePoints 
GIT Problems reduce markedly  Upto present study (4 weeks) 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/02/2014 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not yet Published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  		 The present study is randomized parallel, double arm clinical study to compare effect of Gomutra Haritaki with and without Langhana and Pachana.

Gomutra Haritaki described in Ashtanga Hridaya Samhita Chikitsa Sthana 8/55, consists of Haritaki (Terminalia chebula retz.) and Gomutra (cow urine). For the preparation of Gomutra Haritaki, Haritaki(1 part) was boiled until Gomutra (2.5 part) evaporated and the granules of semisolid consistency were punched into tablets of 500 mg each.

Total 153 patients were registered for the present clinical trial. In Group A, 76 patients were registered, out of them 70 patients completed the treatment while in Group B, 77 patients were registered and out of them 68 patients completed the treatment.

Group A, Langhana and Pachana followed by Gomutra Haritaki
For the purpose of Langhana (light diet) i.e., one time regular meal (lunch) and Mudga Yusha(green gram soup) in dinner for 4 days was advised. This was followed by Pachana for 10 days with Dhanyaka-Shunthi Sidhha Jala.
Dhanyaka-Shunthi Sidhha Jala was prepared by mixing of 400 ml of water with 6 gm drug [ 4.5 gm Dhanyaka (coriandrum sativum Linn.) and 1.5 gm Shunthi (zingiber officinale Rosc.) ] was boiled until 200 ml water was evaporated. This medicated water was given for twice a day at morning and evening 6 pm. After 10 days of Pachana, Gomutra Haritaki was administered in the dose of 500 mg each, 2 tablets with luke warm water (Ushnodaka) before food thrice a day for 8 weeks.

Group B, Placebo capsules followed by Gomutra Haritaki
For initial 14 days, 2 capsules (starch powder) of 500 mg each twice daily were given to compare the effect of placebo with Langhana and Pachana. During this period no diet restriction was done.
Followed by placebo capsules,  Gomutra Haritaki was administered 2 tablets 500 mg each with luke warm water before food thrice a day for 8 weeks.

Patients were assessed before treatment, after 14 days Langhana-Pachana or placebo treatment and after treatment, bio chemical parameters-lipid profile were also done during this interval.

Results:
After 14 days of course with  Langhana and  Pachana in Group A, S. Cholesterol (7.66%), S. Triglyceride (13.56%), S.LDL (7.89%), S.VLDL (15.39%) were decreased which were statistically significant. S.HDL was decreased by 3.36% which was statistically insignificant. In Group B where only placebo treatment was given without diet restriction. S.Cholesterol (0.51%), S. Triglyceride (2.20%), S.VLDL (3.24%), S.HDL (1.15%) were increased which were statistically insignificant. S.LDL was decreased by 0.01% which was statistically insignificant.

Over all effect of therapy which was calculated by difference at baseline and after administration of Gomutra Haritaki  showed that in Group A, S. Cholesterol (8.59%), S.Triglyceride (8.72%), S.LDL(11.45%), S.VLDL (10.76%) were decreased which were statistically significant. S.HDL was decreased by 2.11% which was statistically insignificant where in Group B, S.Cholesterol (9.51%), S. Triglyceride (7.91%), S.LDL (13.14%), S.VLDL (7.63%) were decreased which were also statistically significant. S.HDL was decreased by 2.5% which was statistically insignificant. After applying unpaired t test for comparison of overall effect of Group A and B, it was found that difference of results reported in their Groups on S.Cholesterol, S.Triglyceride, S.LDL, S.VLDL, S.HDL were statistically insignificant.
In Group A, lipid profile was decreased significantly after Langhana and Pachana of 14 days and almost remained stable after administration of Gomutra Haritaki while in Group B no change was observed after placebo for 14 days but lipid profile was significantly reduced after administration of Gomutra Haritaki.
 
 
 
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