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CTRI Number  CTRI/2026/02/103177 [Registered on: 06/02/2026] Trial Registered Prospectively
Last Modified On: 05/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   “A Clinical Study to Assess the Effect of Nirgundi (Vitex negundo) Leaf Extract in the Management of Obesity” 
Scientific Title of Study   Pharmacognostical, Analytical Evaluation and Clinical Efficacy of Nirgundi (Vitex negundo Linn.) leaves (water soluble Extract) in the Management of Sthaulya : A Randomized Placebo-Controlled 
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 Ashim Aryan 
Designation  MD scholar 
Affiliation  Ayurved and Unani Tibbia College and Hospital 
Address  Ayurved and Unani Tibbia College and Hospital Karol Bagh New Delhi 110005
flat no 54,pocket 13,ROHINI SECTOR 24,PIN- 110085
North West
DELHI
110005
India 
Phone  9661324581  
Fax    
Email  ashimarien@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Shalini Varshney 
Designation  Associate Professor 
Affiliation  Ayurved and Unani Tibbia College and Hospital 
Address  Ayurved and Unani Tibbia College and Hospital Karol Bagh New Delhi 110005
Ayurved and Unani Tibbia College and Hospital Karol Bagh New Delhi 110005
Central
DELHI
110005
India 
Phone  9354925050  
Fax    
Email  shalinidr.v7@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ashim Aryan 
Designation  MD scholar 
Affiliation  Ayurved and Unani Tibbia College and Hospital 
Address  Ayurved and Unani Tibbia College and Hospital Karol Bagh New Delhi 110005
flat no 54 pocket 13 3 rd floor Rohini Sector 24 Delhi 110085
North West
DELHI
110005
India 
Phone  9661324581  
Fax    
Email  ashimarien@gmail.com  
 
Source of Monetary or Material Support  
Ayurved and Unani Tibbia College and Hospital , Department of Dravyaguna Karol Bagh Delhi 110005 India  
 
Primary Sponsor  
Name  Ayurved and Unani Tibbia College and Hospital  
Address  Karol Bagh New Delhi 110005 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashim Aryan  Ayurved and Unani Tibbia College and Hospital   Opd No 18 Pg Department Dravyaguna Vigyan Karol Bagh New Delhi 110005
Central
DELHI 		 9661324581

ashimarien@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (Ayurveda)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: MEDOROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: NIRGUNDI LEAVES EXTRACT, Reference: KAIYDEV NIGHANTU AND YOGRATNAKAR , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Luke Warm Water), Additional Information:
2Comparator Arm (Non Ayurveda)-Maize StarchPlacebo
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Both Male and female patients who are willing to participate.
Age 20 to 50 years
BMI more then or equal to 25 kg/m2 and less then or equal to 35 kg/m2
 
 
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 for 3 months.
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   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary outcome

20 percent decrease in body weight

Improvement in objective parameter BMI waist circumference




 		 3 Month



 
 
Secondary Outcome  
Outcome  TimePoints 
change in the subjective parameter like ayuso hrasa javoparodha and daurbalya  3 month 
 
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/ Phase 3 
Date of First Enrollment (India)   15/03/2026 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  


The present study is a prospective, interventional clinical study designed to scientifically evaluate the safety and clinical efficacy of the water-soluble extract of Nirgundi (Vitex negundo Linn.) leaves in human participants. The study will be conducted at a single study center after obtaining approval from the Institutional Ethics Committee and will be registered with the Clinical Trials Registry of India (CTRI).

Methodology

Eligible participants fulfilling the predefined inclusion and exclusion criteria will be enrolled after obtaining written informed consent. The investigational drug, i.e., water-soluble extract of Nirgundi leaves, will be prepared and standardized as per classical Ayurvedic principles and relevant pharmacognostical and analytical guidelines.

Baseline assessment will include detailed clinical evaluation and necessary laboratory investigations to establish safety parameters. Participants will receive the study intervention for a fixed treatment duration as mentioned in the protocol and will be followed up at scheduled intervals for assessment of therapeutic response and safety.

Study Groups

Participants will be allocated into the following groups as per the approved protocol

  • Study Group: Participants receiving the water-soluble extract of Nirgundi leaves in the prescribed dose and duration.

  • Control/Comparator Group : Participants receiving standard care/placebo/controlled intervention as defined in the protocol.

Outcome Measures

The primary outcome will focus on assessment of safety, evaluated through clinical examination and laboratory parameters. Secondary outcomes will include assessment of clinical efficacy parameters relevant to the disease condition under study. All participants will be closely monitored for any adverse events throughout the study period.

Ethical Considerations

The study will be conducted in accordance with Good Clinical Practice (GCP) guidelines and ethical principles. Confidentiality of participant data will be maintained, and participants will have the right to withdraw from the study at any time.


 
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