| CTRI Number |
CTRI/2025/04/085349 [Registered on: 23/04/2025] Trial Registered Prospectively |
| Last Modified On: |
22/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical study of Mahanimba ghan vati in obese adults of age 20-50 years |
|
Scientific Title of Study
|
Anti-obesity activity of Leaf and stem bark of Mahanimba(Melia azedarach Linn.): In-silico, In-vitro and Exploratory clinical study. |
| 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 Aman Singhal |
| Designation |
PG Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
26/14, Street no. 13, Vishwas nagar, Shahdara, Delhi-110032
East
DELHI
110032
India |
| Phone |
8929687821 |
| Fax |
|
| Email |
amansinghal5151@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivani Ghildiyal |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
ALL INDIA INSTITUTE OF AYURVEDA, Gautampuri, Sarita Vihar, New Delhi- 110076
North
DELHI
110076
India |
| Phone |
8765363310 |
| Fax |
|
| Email |
drshivanighildiyal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aman Singhal |
| Designation |
PG Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
26/14, Street no. 13, Vishwas nagar, Shahdara, Delhi-110032
East
DELHI
110032
India |
| Phone |
8929687821 |
| Fax |
|
| Email |
amansinghal5151@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda, Gautampuri, Sarita Vihar, Mathura Road, New Delhi-110076 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda, New Delhi |
| Address |
Gautam Puri, Sarita Vihar, Mathura road, New Delhi- 10076 |
| Type of Sponsor |
Research institution |
|
|
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 Aman Singhal |
OPD and IPD, All India Institute of Ayurveda |
Room NO.16,2, Gautampuri, Sarita Vihar, Mathura road, New Delhi- 110076
East
DELHI |
8929687821
amansinghal5151@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Division of Translational Research and Biostatics, All India Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: MEDOVRUDDHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mahanimba stem bark ghan vati, Reference: Ashtanga Hridya, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: lukewarm water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mahanimba Leaf ghan vati, Reference: Ashtanga Hridya, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
BMI greater than 30 and less than equals to 40 |
|
| ExclusionCriteria |
| Details |
Patients having grade II and III hepatomegaly.
Patients having history of Diabetes Mellitus, PCOD, Thyroid disorders and uncontrolled Hypertension.
Pregnant females and lactating women.
Patients having simultaneous intake of Anticonvulsant, Beta-blockers, Corticosteroid.
Patients taking any other medicines for obesity.
Any study participants condition which is considered by the investigating team to jeopardize. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Objective (Weight, BMI, Body circumference, Lipid Profile, LFT) and subjective (Gradings) parameters |
0th day, 30th, 60th and 90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Change in Vitamin B12 levels.
• Comparative anti-obesity activity of leaf and stem bark of Mahanimba. |
0th day, 30th, 60th and 90th day |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
18/05/2025 |
| 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="0"
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
|
INTRODUCTION Obesity is a concern of public health. Overweight and obesity are lifestyle illnesses that contributes to numerous chronic diseases, including cancers, diabetes, metabolic syndrome, and cardiovascular diseases. Mahanimba is one such tree which is having Tikta and Kashaya rasa and which is well cited in ancient Ayurveda classics with wide indications i.e. Bhrma (giddiness), Chardi (vomiting), Kushta (skin diseases), Hrullas (nausea), Raktavikara , Prameha. These rasa are well cited for medohara action in our ancient texts. Botanically it is identified as Melia azedarach Linn. The tree has been evaluated for its in-vitro antiviral activity, anti-fungal activity, in vitro acaricidal activity, anti-oxidant activity, in-vivo antidiabetic and gastric inhibitory activity etc. but its anti-obesity effect in In-silico, in In-vivo and clinical is yet to be explored. Thus, the present study is taken under consideration. HYPOTHESIS Null hypothesis (H0): Mahanimba leaf ghan vati and stem bark ghan vati does not have anti-obesity activity in In-silico, In-vitro (PL inhibitory assay), and in obese patients. Alternate hypothesis (H1): Mahanimba leaf ghan vati and stem bark ghan vati have anti-obesity activity in In-silico, In-vitro (PL inhibitory assay), and in obese patients. END POINT The patients will be assessed on the basis of basis of reduction in BMI by 1 unit.
|