| CTRI Number |
CTRI/2021/12/038822 [Registered on: 21/12/2021] Trial Registered Prospectively |
| Last Modified On: |
16/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Ayurvedic medicine for Obesity |
|
Scientific Title of Study
|
“EFFECT OF NOVEL AYURVEDA PRODUCTS IN STHAULYA (OBESITY) – A RANDOMIZED PLACEBO CONTROL CLINICAL TRIAL.†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ruddri Raval |
| Designation |
PG Scholar |
| Affiliation |
KAHER Shri BM Kankanwadi Ayurveda Mahavidyalaya |
| Address |
Department of swasthavritta KAHERS Shri BM Kankanwadi Ayurveda Mahavidyalaya Shahapura Belgaum Karnataka 590003 India
Belgaum
KARNATAKA
590003
India |
| Phone |
9428000175 |
| Fax |
|
| Email |
kw0120008-t@kleayurworld.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Patil |
| Designation |
Professor and HOD |
| Affiliation |
KAHER Shri BM Kankanwadi Ayurveda Mahavidyalaya |
| Address |
Department of swasthavritta KAHERS Shri BM Kankanwadi Ayurveda Mahavidyalaya Shahapura Belgaum Karnataka 590003 India
Belgaum
KARNATAKA
590003
India |
| Phone |
9972583954 |
| Fax |
|
| Email |
ashokpatil.kaher@kleayurworld.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Patil |
| Designation |
Professor and HOD |
| Affiliation |
KAHER Shri BM Kankanwadi Ayurveda Mahavidyalaya |
| Address |
Department of swasthavritta KAHERS Shri BM Kankanwadi Ayurveda Mahavidyalaya Shahapura Belgaum Karnataka 590003 India
Belgaum
KARNATAKA
590003
India |
| Phone |
9972583954 |
| Fax |
|
| Email |
ashokpatil.kaher@kleayurworld.edu.in |
|
|
Source of Monetary or Material Support
|
| KAHER SHRI B M KANKANWADI AYURVEDA MAHAVIDYALAYA AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
Dr Ruddri Raval |
| Address |
Dr Ruddri Raval PG Scholar Department of Swasthavritta KAHERS Shri BM Kankanwadi Ayurveda Mahavidyalaya Shahapur Belgaum karnataka 590003 India |
| Type of Sponsor |
Other [(Self)] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Mukund Sabnis MD AYU |
SPECIALIST CLINICIAN FOUNDER PRESIDENT OF JEEVANREKHA AYURVEDA CHIKITSALAYA AND RESEARCH CENTRE JAWAHAR COLONY AURANGABAD MAHARASHTRA 431005 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ruddri Raval |
KAHERS Shri BM Kankanwadi Ayurveda Mahavidyalaya and Hospital |
Department of Swasthavritta
Room number -17
Belgaum
KARNATAKA |
9428000175
kw0120008-t@kleayurworld.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: STHAULYA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: novel ayurveda products, Reference: charak sutra 4 lekhaneeya mahakashaya, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Novel ayurveda products, Reference: charak sutra 4th chapter lekhneeya mahakashya , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: | | 3 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Placebo, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients from either sex with classical sign and symptoms of Sthaulya
2.Patients of age group 20 to 50 years
3.Patients with BMI greater than or equal to 30 kg per meter square
|
|
| ExclusionCriteria |
| Details |
1.Patients below 20 and above 50 years of age
2. Patients having major systemic disorders or other illnesses such as Hypothyroidism Cushing syndrome Hypersensitivity and Diabetes which interfere with the present study
3.Patients with serious disease limiting life expectancy
4.Pregnancy and lactating mothers
5.Cognitive impairment congenital deformities
6.Not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Novel Ayurveda Products will be effective in Sthaulya (obesity) |
baseline and on 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.serum insulin
2.HsCRP levels |
baseline and on 30th day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/01/2022 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is to evaluate the efficacy of Novel Ayurveda Products in sthaulya (obesity) when administered for 30 days at dose 2 tab and 2 capsule BD before meal . The expected outcome is Novel Ayurveda Products will be effective in Sthaulya (obesity) |