| CTRI Number |
CTRI/2022/07/043950 [Registered on: 12/07/2022] Trial Registered Prospectively |
| Last Modified On: |
20/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Curative] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study the efficacy of beeja and moola of Madhavilata(Hiptage benghalensis L.) in Udar-Sthaulya(Central Obesity) |
|
Scientific Title of Study
|
Preliminary standardization of beeja and moola of Madhavilata(Hiptage benghalensis L.) and its comparative clinical assessment in Udara-Sthaulya(Central Obesity) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kevinaben Mukeshbhai Patel |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurved College And Hospital, Vadodara |
| Address |
Post graduate department of Dravyaguna, Government Ayurved College and Hospital, Ajwa road, Dhanwantari marg, Panigate, Vadodara
Vadodara
GUJARAT
390019
India |
| Phone |
8320703930 |
| Fax |
|
| Email |
patelkevina046@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dilip K Jani |
| Designation |
H.O.D and Proffesor |
| Affiliation |
Government Ayurved College and Hospital, Vadodara |
| Address |
Post graduate department of Dravyaguna, Government Ayurved College and Hospital, Ajwa road, Dhanwantari marg, Panigate, Vadodara
Vadodara
GUJARAT
390019
India |
| Phone |
9925941861 |
| Fax |
|
| Email |
drdilipjn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suman Singh |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurved College and Hospital, Vadodara |
| Address |
Post graduate department of Dravyaguna, Government Ayurved College and Hospital, Ajwa road, Dhanwantari marg, Panigate, Vadodara
Vadodara
GUJARAT
390019
India |
| Phone |
9510172204 |
| Fax |
|
| Email |
snghsmn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post graduate department of Dravyaguna, Government Ayurved College and Hospital, Ajwa road, Dhanwantari marg, Panigate, Vadodara-390019 |
|
|
Primary Sponsor
|
| Name |
Government Ayurved Hospital Vadodara |
| Address |
Post graduate department of Dravyaguna, Government Ayurved Hospital, Ajwa road, Dhanwantari marg, Panigate, Vadodara-390019 |
| 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 |
| Kevinaben Patel |
Government Ayurved Hospital, Vadodara |
OPD Dravyaguna Department
Vadodara
Gujarat
Vadodara
GUJARAT |
8320703930
patelkevina046@gmail.com |
|
|
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:E65||Localized adiposity. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Madhavilata Beeja, Reference: Bha.Pra.Chi.39/24, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 6 Weeks, anupAna/sahapAna: Yes(details: -Purana Madhu), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Maddhavilata Moola, Reference: Chakradatta 62/64, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 6 Weeks, anupAna/sahapAna: Yes(details: -Mathita), Additional Information: - | | 3 | Comparator Arm (Non Ayurveda) | | - | Placebo | Dose: 3(g)
Frequency: bd
Bhaishajya Kal: Pragbhakta
Anupan: Jala
Route of administration: Oral |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients having any two among these will be included.
1.BMI>25, BMI<40
2.waist circumference - >102cm(M), >88cm(F)
3.Waist Hip ratio- >0.9(M), >0.85cm(F)
|
|
| ExclusionCriteria |
| Details |
1.Pregnant women and Lactating mother
2.Hypothyrodism, Drug induced obesity
DM, HTN etc.
3.Any other serious systemic illness like AIDS, T.B., Malignancy etc |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Waist circumference |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Weight, BMI, Waist Hip ratio/Waist Height Ratio
Chala udara, Atikshudha |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2022 |
| Date of Study Completion (India) |
05/08/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
05/08/2023 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Clinical study has obtained Institutional Ethics committee clearance (GAC/VAD/IEC/69/2021,
Date-15/09/2021) and registered at Clinical Trial Registry of India, ICMR, New
Delhi, vide CTRI/2022/07/043950 [Registered on 12/07/2022]. Study type was single
blind randomized comparative clinical trial. Selected patients were randomly
divided into three groups (i.e, Group A – Madhavilata Beeja Churna, B – Madhavilata
Moola Churna and C - Placebo) using computer generated randomization
sequence in which 54 patients were selected and randomly divided into three
groups (18 patients in each group). Total 50 patients (i.e, 18 patients in Group
A, 16 patients in Group B, 18 patients in Group C) completed the treatment with
dose (3gm – 2 times per day before meal). Group A & B shows highly
significant result as compared to placebo. Non-significant difference observed between
effects of Group A & B.
|