| CTRI Number |
CTRI/2022/07/043980 [Registered on: 13/07/2022] Trial Registered Prospectively |
| Last Modified On: |
13/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [curative] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical trial to study the effects of two drugs, Gomutra triphala vati and Navaka guggulu in patients of sthoulya who are having overweight and obesity (class one) dividing them in two groups randomly and giving medicines for about one and half months |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study to evaluate the efficacy of Gomutra Triphala vati in the management of Sthoulya. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prithvi N Bhat |
| Designation |
Second year PG Scholar |
| Affiliation |
Alvas Ayurveda Medical College, Moodbidri |
| Address |
Dr.Prithvi N Bhat
second year PG scholar
Department of PG studies in Kayachikitsa
Alvas Ayurveda Medical College and Hospital Vidyagiri Moodidri Dakshina Kannada PIN 574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
7349158836 |
| Fax |
|
| Email |
prithvigurumane@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Susheel shetty |
| Designation |
Professor and HOD |
| Affiliation |
Alvas Ayurveda Medical College Moodbidri |
| Address |
Professor and Head of the Department
Department of PG studies in Kayachikitsa
Alvas Ayurveda Medical College Moodbidri D.k. Karnataka PIN 574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9980431676 |
| Fax |
|
| Email |
shettysusheel13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Susheel shetty |
| Designation |
Professor and HOD |
| Affiliation |
Alvas Ayurveda Medical College Moodbidri |
| Address |
Professor and Head of the Department
Department of PG studies in Kayachikitsa
Alvas Ayurveda Medical College Moodbidri D.k. Karnataka PIN 574227
Shimoga
KARNATAKA
574227
India |
| Phone |
9980431676 |
| Fax |
|
| Email |
shettysusheel13@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas Ayurveda Medical College and Hospital Moodbidri |
|
|
Primary Sponsor
|
| Name |
Dr Prithvi N bhat |
| Address |
Shri Gurujyoti Indira Nagara
Siddapura Uttara kannada
PIN: 581355 |
| 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 Prithvi N Bhat |
Alvas Ayurveda Medical College and Hospital |
Kayachikitsa OPD and IPD
Alvas Ayurveda Medical College and Hospital, Moodbidri
Dakshina Kannada
KARNATAKA |
7349158836
prithvigurumane@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Clinical Ethics Committee ICEC/AAMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: ATISTHAULYAMÂ (KEVALA-KAPHA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: navaka guggulu, Reference: chakradatta medorogaadhikaara, Route: Oral, Dosage Form: Guggulu , Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -ushnodaka), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: gomutra triphala vati, Reference: vangasena samhita medorogaadhikaara, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -ushnodaka), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having BMI ranging from
1 25 to 29.9 Kg/m2( Over weight )
2 30 to 34.9 Kg/m2(Class one Obesity )
Associated with any two of the below mentioned features
1 Atikshudha
2 Atisweda
3 Atinidra
4 Alasya/ Utsaha hani
5 Atipipasa
6 Alpa shwasa
7 Daurgandhya
8 Chala Sphik ,Udara, Stana
9 Subjects who are ready to give written informed consent |
|
| ExclusionCriteria |
| Details |
1 Subjects who are known case of Diabetes Mellitus, Hypertension, Ischemic Heart Disease or any other Systemic diseases.
2 Obese patients with known Endocrine Dysfunctions.
3 Pregnant women and Lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The effect of the treatment will be assessed based on detailed case proforma adopting standard scoring methods of subjective parameters such as • Atikshudha
• Atisweda
• Atinidra
• Alasya/ Utsaha hani
• Atipipasa
• Alpa shwasa
• Daurgandhya
• Chala Sphik ,Udara, Stana
and objective parameters such as • Body Weight
• BMI
• Waist Hip ratio
pre and post interventional assessment will be done. |
The effect of the treatment will be assessed before treatment on day 0, then during treatment on day 16, day 31,day 46 and after treatment follow up on day 61 total of 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/07/2022 |
| 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="15" |
|
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
|
This is a randomized controlled clinical study to evaluate the efficacy of Gomutra Triphala Vati in the management of sthoulya for a duration of 60 days 60 patients in OPD and IPD of PG studies in Kayachikitsa of Alvas Ayurveda Medical College and hospital , Moodbidri vidyagiri Dakshina Kannada, Karnataka ,India. Assesment will be done based on detailed case proforma adopting standard scoring methods of Subjective and Objective parameters Pre and Post assesment will be done. Clinical Symptoms will be graded and scores will be given accordingly. |