| CTRI Number |
CTRI/2023/12/060602 [Registered on: 21/12/2023] Trial Registered Prospectively |
| Last Modified On: |
18/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative research study of Krimighnadi Ghanwati & Mustadikwath Ghanwati in Sthoulya(Obesity) |
|
Scientific Title of Study
|
Randomise Controlled Clinical Trial to Compare Krimighnadi Ghanwati & Mustadikwath Ghanwati in Management of Sthoulya (obesity) |
| Trial Acronym |
Krimighnadi Ghanwati |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Meera Subhashrao Solanke |
| Designation |
Ph D scholar |
| Affiliation |
BVDU College of Ayurved |
| Address |
Bharati Vidhyapeeth Deemed to be University College of Ayurved ,Katraj Pune
Bharati Vidhyapeeth Deemed to be University College of Ayurved ,Katraj Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
7447801802 |
| Fax |
|
| Email |
meerasolanke20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay A Dhurve |
| Designation |
Associate Professor |
| Affiliation |
BVDU College of Ayurved |
| Address |
Bharati Vidhypeeth Deemed to be University College of Ayurved ,Katraj Pune
Bharati Vidhypeeth Deemed to be University College of Ayurved ,Katraj Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9850044207 |
| Fax |
|
| Email |
dr.sanjaydhurve@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrMeera Subhashrao Solanke |
| Designation |
Ph D scholar |
| Affiliation |
BVDU College of Ayurved |
| Address |
Bharati Vidhypeeth Deemed to be University College of Ayurved ,Katraj Pune
Bharati Vidhypeeth Deemed to be University College of Ayurved ,Katraj Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
|
| Fax |
|
| Email |
meerasolanke20@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharti vidhypeeth hospital katraj pune |
|
|
Primary Sponsor
|
| Name |
Meera solanke |
| Address |
Bharti Vidhypeeth University College of Ayurved and hospital pune -43 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| DrMeera Solanke |
Bharati Vidypeeth Deemed to be University Ayurved Hospital katraj pune |
Department of Kayachikitsa Bharati vidypeeth deemed to be University Ayurved Hospital Katraj Pune
Pune
MAHARASHTRA |
7447801802
meerasolanke20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BVCOAEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: STHULARUSHKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Krimighanadi Ghanwati, Reference: Sahastrayog Kashay Prakaran-Page No-29, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Honey), Additional Information: Honey 6 Gm Twice a day with Koshnajal | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mustadikwath Ghanvati, Reference: Cha.Su.23/12-14, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Koshnajal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having signs and symptoms of Sthoulya explained in Ayurvedic Texts
2.Patients from age group 16-60 years
3.Patients of both genders.
4.Patients having BMI equal or more than 25.
|
|
| ExclusionCriteria |
| Details |
1.Drug induced obesity
2.Obesity due to certain secondary causes
3.Hormonal disorders
4.Pregnant women
5.Disease associated obesity patient.
6.BMI less than 25.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Sign & Symptoms of Sthoulya Parameters like Atikshudha,Atinidra,Atisweda,Swedadurgandhi,Alasya,Shramshwasa,Atipipasa,Angasad,Alpamaithun,Udarayam(cm),Sphikayam(cm),Stanaayam(cm),Reduction in Weight,BMI,Skinfold thickness,CBC,Urine Routine & Microscopic,BSL Fasting |
0,30,60 ,90 And 120 Days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in BMI level, lipid profile, anthropometry. |
0 ,30 ,60and 90 days |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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 2 |
|
Date of First Enrollment (India)
|
29/12/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
An open label, Randomise Controlled Clinical Trial to Compare Krimighnadi Ghanwati & Mustadikwath Ghanwati in Management of Sthoulya (obesity),total 102 patient fulfilling the clinical criteria of sthoulya between age group 16 to 60 will be selected from kaychikitsa department and alloted randomly in 2 groups,drugs will be given as 500mg tablet after lunch and dinner ,pathya apathya will be advised to the patient during trial,duration of trial will be of 90 days ,treatment start day -0 follow up on 30,60,90days patient will be reviewed on 120th day
|