| CTRI Number |
CTRI/2024/08/073134 [Registered on: 29/08/2024] Trial Registered Prospectively |
| Last Modified On: |
19/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Haritaki vati (Terminalia Chebula Retz) in management of Sthaulya |
|
Scientific Title of Study
|
Evaluation of efficacy of Haritaki Vati (Terminalia Chebula Retz) Vs Routine care in the management of Sthaulya (overweight)- RCT |
| 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 Vishal Chinchone |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre |
| Address |
Room No 30 Department of Kayachikitsa Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha Maharashtra
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9545650987 |
| Fax |
|
| Email |
vishalchinchone2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaishali Kuchewar |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre |
| Address |
Room No 30 Department of Kayachikitsa Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha Maharashtra
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha Maharashtr
Wardha
MAHARASHTRA
442001
India |
| Phone |
9420998747 |
| Fax |
|
| Email |
vkuchewar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishal Chinchone |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre |
| Address |
Room No 30 Department of Kayachikitsa Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha Maharashtra
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha Maharashtr
Wardha
MAHARASHTRA
442001
India |
| Phone |
9545650987 |
| Fax |
|
| Email |
vishalchinchone2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha
Pin Code 442001
Maharashtra |
|
|
Primary Sponsor
|
| Name |
Dr Vishal Chinchone |
| Address |
Room No 30 Department of Kayachikitsa Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha Maharashtra
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vishal Chinchone |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha Maharashtra |
Room No 30 Department of Kayachikitsa Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha Maharashtra
Wardha
MAHARASHTRA |
9545650987
vishalchinchone2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MGACH&RC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Overweight patient between age group of 19 to 30 years having BMI 25 to 29.9 kg/m2.
|
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Haritaki Vati, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Lukewarm Water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Starch Vati | It is a blinder in the wet granulation process of massing and screening. given orally in the vati form with dose of 500 mg twice a day for 90 days with lukewarm water . |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients willing to Participate in the Study and give written informed
consent
2 Age between 19 to 30 years of either sex
3 Patients having BMI in between 25 to 29.9 kilogram meter square |
|
| ExclusionCriteria |
| Details |
1 Drug induced overweight.
2 Subject who is on anti-lipidemic, steroid medication.
3 K/C/O Hypothyroidism, Diabetes, Cardiovascular, Renal disorder, hypertension.
4 Pregnant and lactating women.
5 Subjects with any serious concomitant illnesses or any systemic illness that is clinically significant and requires a high dosage of medicine.
6 Subjects with a history of alcohol consumption, drug dependence, or dependence on caffeine or nicotine.
7 Subjects who are going to gym.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy of Lekhaniya effect of Haritaki vati in BMI body weight arm and
waist circumference of both the groups on 0th 30th 60th and 90th day of treatment |
To assess the efficacy of Lekhaniya effect of Haritaki vati in BMI body weight arm and
waist circumference of both the groups on 0th 30th 60th and 90th day of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy of Lekhaniya effect of Haritaki vati in BMI body weight arm and
waist circumference of both the groups on 0th 30th 60th and 90th day of treatment |
120 Days |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
25/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/12/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="1"
Days="10" |
|
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
|
The volunteers will be informed about the study protocol. willing participants will be randomly selected as per lottery method. clinical research format will be prepared and validated. prior to the study approval will be taken from IEC, MGACHRC salod hirapur Wardha and CTRI registration will be done. After selection, participants will be tested individually and selected according to selection criteria. they have divided into two groups the trial is a parallel-group, randomized double blind double dummy clinical standard control trial. it will include 90 days treatment period and 90th day follow-up period. |