| CTRI Number |
CTRI/2021/03/032449 [Registered on: 31/03/2021] Trial Registered Prospectively |
| Last Modified On: |
21/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of GomutraTriphala Vati and Tab Atorvastatin in Sthaulya(Obesity and Hyperlipidemia) |
|
Scientific Title of Study
|
A Randomized controlled clinical trial to evaluvate the efficacy between GomutraTriphala Vati and Atorvastatin in the management of Medovruddhi in Sthaulya with special reference to Hyperlipidemia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gargi Sanjay Limaye |
| Designation |
PG Scholar |
| Affiliation |
PDEAS College of Ayurved and Research Centre,Nigdi,Pune |
| Address |
PDEAs College of Ayurved and Research Centre,Third floor,Kayachikitsa Department, Sector no-25,Pradhikaran,Nigdi,Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9405929955 |
| Fax |
|
| Email |
gargilimaye089@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Medha Mahesh Joshi |
| Designation |
H.O.D. of Kayachikitsa department |
| Affiliation |
PDEAS College of Ayurved and Research Centre,Nigdi ,Pune |
| Address |
PDEAs College of Ayurved and Research Centre,Third floor,Kayachikitsa Department, Sector no-25,Pradhikaran,Nigdi,Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9881465798 |
| Fax |
|
| Email |
medhamaheshjoshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gargi Sanjay Limaye |
| Designation |
PG Scholar |
| Affiliation |
PDEAS College of Ayurved and Research Centre,Nigdi,Pune |
| Address |
PDEAs College of Ayurved and Research Centre,Third floor,Kayachikitsa Department, Sector no-25,Pradhikaran,Nigdi,Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9405929955 |
| Fax |
|
| Email |
gargilimaye089@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Centre .Sector no-25,Nigdi,Pune 411044 |
|
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Primary Sponsor
|
| Name |
PDEAs College of Ayurved and Research Centre NigdiPune |
| Address |
PDEAs College of Ayurved and Research Centre,Sector no-25,Pradhikaran,Nigdi,Pune 411044 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gargi Sanjay Limaye |
Ayurved Rugnalay and Sterling Multispeciality Hospital,Nigdi,Pune |
Vitthal Rukmini road,Sector no-27,Kayachikitsa O.P.D.no 117,Ground floor,Nigdi Pradhikaran, Pune
Pune
MAHARASHTRA |
9405929955
gargilimaye089@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E660||Obesity due to excess calories. Ayurveda Condition: MEDOVRUDDHIH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GomutraTriphala Vati |
Group A will be treated with GomutraTriphala vati containing Gomutra,Triphala. GomutraTriphala Vati will be given orally in the dose of 500 mg twice a day before meal with lukewarm water in the age group of 25-65 years which includes follow up on 15th,30th,45th,60th day. |
| Comparator Agent |
Tab.Atorvastatin 10 mg |
Group B will be treated with Tab.Atorvastatin.Tab.Atorvastatin will be given orally in the dose of 10 mg once a day at night with water in the age group of 25-65years which includes follow up on 15th,30th,45th,60th day. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1Patients suffering from Medovruddhijanit symptoms in Sthaulya.
2Patients who are having two or more following symptoms will be included for the study
1 SHWASADHIKYA
2 NIDRADHIKYA
3 AAYAS AKSHAMATA
4 JADDYA
5 BALAHEENATA
6 ATI KSHUDHA
7 ATI TRUSHNA
3Age group having 25 to 65 years age,irrespective of any gender,socio economic status and religion.
4B.M.I 25.0 to 35 kg/m2.
5Patient having Serum Total Cholesterol Level more than 200mg/dl 6Patient having Serum Triglyceride Level more than 150mg/dl |
|
| ExclusionCriteria |
| Details |
1Pregnant and Lactating women.
2Known cases of Uncontrolled Diabetes Mellitus with Its Complications.
3Known cases of Major systemic diseases such as TB,AIDS,IHD,CA,Renal and Cerebral diseases.
4Known cases of Acute complications like Coronary Heart Disease,Hepatitis.
5High risk (above 65 yrs age,known cases of HTN,DM,COPD)
6Comorbid patients Suspected for Covid-19. Suspected Covid-19 patients having symptoms as per ICMR guidelines. |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of GomutraTriphala Vati 500 mg twice a day before meal with lukewarm water with Tab.Atorvastatin 10 mg once a day at night with water in Medovruddhi in Sthaulya with special reference to Hyperlipidemia within 60 days |
60 days with follow up on 15th,30th,45th,60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare and study the efficacy of GomutraTriphala Vati.
2.To compare and study the efficacy of Tab.Atorvastatin
3.To study the adverse effects if any. |
60 days with follow up on 15th,30th,45th,60th day |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
05/04/2021 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Email at gargilimaye089@gmail.com
- For how long will this data be available start date provided 05-04-2021 and end date provided 23-06-2023?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Being overweight iscommon problem of todays era. It is also associated most of the times with lipid level changes due to unhealthy habits such as sedentary life style,eating junk food,lack of exercise, stress.People are generally considered obese when BMI is above 25 kg/m2 and Hyperlipidemia is when Serum Cholesterol level is more than 200 mg/dl and Serum Triglyceride level more than 150 mg/dl.According to WHO overweight and obese are among leading causes of death globally.According to Ayurveda Medovruddhi especially in Sthaulya is mainly due to Meda and Kapha dushti.Therefore medoghna and kaphaghna properties of the drug will be used for treatment of Medovruddhi in Sthaulya. The main objective of this research work is to provide consolidated report on uses of properties of GomutraTriphala Vati and Tab.Atorvastatin in the management of Medovruddhi in Sthaulya with special reference to Hyperlipidemia. |