| CTRI Number |
CTRI/2024/01/061988 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
20/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Triphala Ghanavati in Sthaulya |
|
Scientific Title of Study
|
Randomised open controlled clinical trial to evaluate the efficacy of Triphala Ghanavati in the management of Sthaulya w.s.r. to Obesity
|
| 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 Shivam Pramod Phopse |
| Designation |
PG Scholar |
| Affiliation |
Yashwant ayurvedic college and post graduate training and research centre kodoli |
| Address |
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli
OPD No 17 kayachikitsa Department Second Floor Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Tal Panhala Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8459006251 |
| Fax |
|
| Email |
patilshivampramod@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dipali Swami |
| Designation |
Associate Professor kayachikitsa department |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli |
| Address |
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli
OPD No 17 kayachikitsa Department Second Floor Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Tal Panhala Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9960003947 |
| Fax |
|
| Email |
drdipaliswamis@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivam Pramod Phopse |
| Designation |
Pg Scholar |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli |
| Address |
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli
OPD No 17 kayachikitsa Department Second Floor Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Tal Panhala Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8459006251 |
| Fax |
|
| Email |
patilshivampramod@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli |
|
|
Primary Sponsor
|
| Name |
Dr Shivam Pramod Phopse |
| Address |
OPD No 17 kayachikitsa Department Second Floor Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Tal Panhala Dist Kolhapur MAHARASHTRA
416114
India |
| 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 |
| Dr Shivam Pramod Phopse |
Yashwant Charitable Hospital |
OPD No 17 kayachikitsa Department Second Floor Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Tal Panhala Dist Kolhapur MAHARASHTRA
416114
India
Kolhapur
MAHARASHTRA |
8459006251
patilshivampramod@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Yashwant Ayurvedic College PGT and RC Kodol |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: MEDOVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Triphala ghanvati , Reference: Sharangdhar samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -madhu), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Navaka guggulu , Reference: Bhaishajya ratnavali , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -koshna jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having signs and symptoms of sthaulya
Patients diagnosed with sthaulya
Patient irrespective of caste income group occupation |
|
| ExclusionCriteria |
| Details |
Patient with clinical evidence of heart failure, serious hepatic disorder.
Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of Triphala ghanvati in sthaulya w s r to obesity on assessment of subjective parameters such as angachalatva atipipasa atikshuda swedadhikya kshudraswasa dourgandya |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To asses the effect of Triphala ghanvati in signs & symptoms of sthaulya such as angachalatva atipipasa atikshuda swedadhikya kshudraswasa dourgandya
To assess improvement by signs symptoms & gradation of assessment criteria
To study etiopathology of sthaulya in detail according to ayurveda & obesity in detail according to modern text
To improve quality of life & reduce discomfort of patient
To achieve the outcome of study in 90 days |
90 days |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
30/01/2024 |
| 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
|
This is randomised open controlled clinical study to evaluate the efficacy of Triphala ghanvati In sthaulya observation will be made upon symptoms of sthaulya study will be
carried out in OPD of kayachikitsa department of Yashwant Charitable Hospital Kodoli |