| CTRI Number |
CTRI/2020/02/023385 [Registered on: 17/02/2020] Trial Registered Prospectively |
| Last Modified On: |
20/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
EFFECT OF RASANJANA GHANAVATI IN OBESITY WITH INSULIN RESISTANCE |
|
Scientific Title of Study
|
RANDOMIZED OPEN CONTROLLED CLINICAL TRIAL ON EFFICACY OF RASANJANA GHANAVATI IN STHAULYA WITH SPECIAL REFERENCE TO OBESITY WITH INSULIN RESISTANCE |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Borakhade Vasundhara Ramdas |
| Designation |
Associate Professor |
| Affiliation |
Yashwant Ayurvedic College Kodoli |
| Address |
Yashwant Ayurvedic College Post graduate research and training center Kodoli.
Shastri Nagar Akola
Akola
MAHARASHTRA
416114
India |
| Phone |
9822885710 |
| Fax |
|
| Email |
vasudha.borakhade@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Wagh surya kiran parshuram |
| Designation |
Professor |
| Affiliation |
Yashwant Ayurvedic College Kodoli |
| Address |
Yashwant Ayurvedic College Post graduate research and training center Kodoli.
Shastri Nagar Akola
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9822846910 |
| Fax |
|
| Email |
Suryakiran_wagh@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Borakhade Vasundhara Ramdas |
| Designation |
Associate Professor |
| Affiliation |
Yashwant Ayurvedic College Kodoli |
| Address |
Yashwant Ayurvedic College Post graduate research and training center Kodoli.
Shastri Nagar Akola
Akola
MAHARASHTRA
416114
India |
| Phone |
9822885710 |
| Fax |
|
| Email |
vasudha.borakhade@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Borakhade V R |
| Address |
Yashwant Ayurvedic College
Kodoli |
| Type of Sponsor |
Other [] |
|
|
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 Borakhade Vasundhara Ramdas |
Yashwant Ayurvedic Hospital Kodoli |
Kayachikitsa Department room number 15.Kodoli 416114
Kolhapur
MAHARASHTRA |
9822885710
vasudha.borakhade@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Intitutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E660||Obesity due to excess calories, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group Tablet Metformin |
Tablet Metformin 500mg two times a day with water before meals.
Advice to avoid sweets.
Advice brisk walking.Study duration is 90 days in both groups |
| Intervention |
Trial group Rasanjanaghanavati.
|
rasanjanaghanavati 500mg two times a day with water.
intervention is given before meals.
Advice to avoid sweets .
Advice brisk walking. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having BMI above 30
HOMA IR test value more than 1.9
Irrespective of gender religion occupation education economical status |
|
| ExclusionCriteria |
| Details |
Pregnancy lactating mother cardiovascular complication |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of rasanjanaghanavati in sthaulya with special reference to obesity with insulin resistance |
90days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in weight
Reduction in BMI
Reduction in insulin resistance |
90 days |
|
|
Target Sample Size
|
Total Sample Size="136"
Sample Size from India="136"
Final Enrollment numbers achieved (Total)= "136"
Final Enrollment numbers achieved (India)="136" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
17/02/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is randomized open controlled clinical trial for efficacy of Rasanjana ghanavati in sthaulya with special reference to obesity with insulin resistance.Primary out come is effect of rasanjana ghanavati on sthaulya & obesity with insulin resistance.Secondary outcome is reduction in weight,reduction in BMI, reduction in insulin resistance. |