| CTRI Number |
CTRI/2025/04/083927 [Registered on: 02/04/2025] Trial Registered Prospectively |
| Last Modified On: |
30/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Management of obesity by punarnavadi kwath |
|
Scientific Title of Study
|
Studies on karya karanavada with special reference to effect of punarnavadi kwath on certain biochemical and anthropometric profiles in individuals with obesity (sthaulya roga) |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Partha Biswas |
| Designation |
Professor and HOD |
| Affiliation |
Institute of post graduate ayurvedic education and research at shyamadas vaidya shastra pith |
| Address |
Institute of post graduate ayurvedic education and research at shyamadas vaidya shastra pith 294 3 1 APC road kolkata 700009 West bengal
Kolkata
WEST BENGAL
700009
India |
| Phone |
9433725917 |
| Fax |
|
| Email |
drpartha264@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Partha Biswas |
| Designation |
Professor and HOD |
| Affiliation |
Institute of post graduate ayurvedic education and research at shyamadas vaidya shastra pith |
| Address |
Institute of post graduate ayurvedic education and research at shyamadas vaidya shastra pith 294,3/1 APC road, kolkata 700009 West bengal
Kolkata
WEST BENGAL
700009
India |
| Phone |
9433725917 |
| Fax |
|
| Email |
drpartha264@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Partha Biswas |
| Designation |
Professor and HOD |
| Affiliation |
Institute of post graduate ayurvedic education and research at shyamadas vaidya shastra pith |
| Address |
Institute of post graduate ayurvedic education and research at shyamadas vaidya shastra pith 294 3 1 APC road kolkata 700009 West bengal
Kolkata
WEST BENGAL
700009
India |
| Phone |
9433725917 |
| Fax |
|
| Email |
drpartha264@gmail.com |
|
|
Source of Monetary or Material Support
|
| Funded by Institute of post graduate ayurvedic education and research at SVSP
294 3 1 Acharya prafulla chandra road kolkata - 700009
West bengal India |
|
|
Primary Sponsor
|
| Name |
Institute of post graduate ayurvedic education and research at s.v.s.p |
| Address |
Institute of post graduate ayurvedic education and research at s.v.s.p 294 3 1 apc road kolkata 700009 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tania Sen |
Institute of post graduate ayurvedic education and research at SVSP |
OPD NUMBER 2, DEPARTMENT OF SAMHITA SIDDHANT,
294,3/1 acharya prafulla chandra road kolkata- 700009
Kolkata
WEST BENGAL |
8787783959
taniasen2016@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee for clinical trial on human subjects I.P.G.A.E.&R kolkata |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E660||Obesity due to excess calories. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Punarnavadi kwath , Reference: Bhaisajya ratnavali volume 2. chapter 42 sloke no 135, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -water), Additional Information: Placebo is use as a comparator. Placebo will consume as same colour same consistency and same period of time and same dose with the treated drug. | | 2 | Comparator Arm (Non Ayurveda) | | - | Placebo | Placebo will consume as same colour same consistency and same period of time and same dose with the treated drug.
40 ml dose each day twice daily for 12 weeks. |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Irrespective of sex race religion.
2. Age 20 years to 70 years.
3. BMI 30 to 39.9 |
|
| ExclusionCriteria |
| Details |
1. BMI not less than 30
2. Heart disease renal failure.
3. Diseases like PCOS Crushing syndrome hypothyroidism.
4. Individual those who are taking oral contraceptive.
5. Pregnant lady.
6. Individual those under taking anti obesity drug birth control pill.
7. Heavy alcohol intake.
8. Uncontrolled type 2 diabetes. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To explore the effect of punarnavadi kwath on BMI in individuals with obesity. |
4th 8th and 12th weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To explore the status of lipid profile & other relevant biochemical parameters in individual with obesity. |
4th 8th & 12th weeks. |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
08/03/2027 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Introduction:
Obesity and overweight have emerged at alarming rate in the world during the last three decades. Obesity is a common disorder usually caused by the interaction of genetic, nutritional and environmental factors. It has now become one of the most important health issues of the modern society around the world. the incidence of obesity is increasing exponentially and it has been revealed that about 500 million adults are obese worldwide. The theory of karya karana bhava is explained by philosophers. The Sankhyas described this theory as Satkarya vada. This theory explained that for any karya (effect) there must be a karana and that karana should be sat that is existent.
Objective of the study:
To explore the effect of punarnavadi kwath on BMI in individuals with obesity. To briefly review the potential link between principal of karya karanavada and manifestation of obesity in human.
Materials and methods:
A randomized double blind placebo control two arm parallel study will be conducted in the department of Ayurveda Samhita and Siddhanta, at IPGAE&R kolkata. |