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CTRI Number  CTRI/2025/05/086447 [Registered on: 06/05/2025] Trial Registered Prospectively
Last Modified On: 06/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study on the Effect of Pippali Root Extract (Piper longum) in Managment of Obesity.  
Scientific Title of Study   A Randomised control study of Pippali mool (root of pipper longum Linn) arka in Sthaulya . 
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 Sayali Sunil Thopate  
Designation  MD Scholar Dravyaguna 
Affiliation  APMs ayurvedic mahavidyalaya Sion Mumbai  
Address  4th floor department of dravyagun APMs ayurvedic mahavidyalaya Sion Mumbai near Sion Railway station mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  8830769788  
Fax    
Email  sayalithopate5@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrPritam Vinay Chindarkar 
Designation  Professor Department of dravygun  
Affiliation  APMs ayurvedic mahavidyalaya Sion Mumbai  
Address  4th floor department of dravyagun APMs ayurvedic mahavidyalaya Sion Mumbai near Sion Railway station mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  7045320847  
Fax    
Email  drpritam_chindarkar@yahoo.com  
 
Details of Contact Person
Public Query  
Name  DrPritam Vinay Chindarkar 
Designation  Professor Department of dravygun  
Affiliation  APMs ayurvedic mahavidyalaya Sion Mumbai  
Address  4th floor department of dravyagun APMs ayurvedic mahavidyalaya Sion Mumbai near Sion Railway station mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  7045320847  
Fax    
Email  drpritam_chindarkar@yahoo.com  
 
Source of Monetary or Material Support  
opd number 7 APMs Ayurvedic Mahavidyalaya and seth R V Ayurved Hospital Near Sion railway station, Sion, mumbai 
 
Primary Sponsor  
Name  Dr. Sayali sunil Thopate  
Address  APMs ayurvedic mahavidyalaya Sion near Sion Railway station Sion Mumbai 400022 
Type of Sponsor  Other [Self ] 
 
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 Sayali Thopate  Seth R.V. Ayurvedic Hospital  opd number 7 APMs Ayurvedic Mahavidyalaya and seth R V Ayurved Hospital Near Sion railway station, Sion, mumbai
Mumbai
MAHARASHTRA 		 8830769788

sayalithopate5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sion Ayurved Mahavidyalaya IEC  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 ArmDrugOther than Classical(1) Medicine Name: Pippali mool arka, Reference: NA, Route: Oral, Dosage Form: Arka, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: jala), Additional Information: -
2Comparator Arm (Non Ayurveda)-distilled water
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Irrespective of gender (Male, female)
Patient with BMI ranging between 25-40
Patient with classical symptoms of sthaulya roga like Kshudrashwasa,
Nidradhikya(Drowsiness),Pipasa(Thirst),Daurbalya(Weakness),Kshudhadhiky
a(Excessive Hunger), Swedadhikya (Sweating), Daurgandhya (Bad Smell)
Age-20-50years
Religion-no barrier 
 
ExclusionCriteria 
Details  Patient having major cardiac disorders, hormonal disorders,Infectious disease or
any other major illness, pregnancy, lactating mothers and
Diabetes mellitus.
Patient with BMI greater than 40
Patient on prolonged medications like corticosteroids, NSAIDS, antidepressants,
or any drugs that may influence on the outcome of study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Weight
BMI
Waist circumference
Hip
circumference
Waist/Hip
ratio
Mid-upper arm
circumference  		 15 days after 1st visit
30 days after 2nd visit
45 day after 3rd visit  
 
Secondary Outcome     
Target Sample Size   Total Sample Size="43"
Sample Size from India="43" 
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)   19/05/2025 
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="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  
Obesity (Sthaulya) is a growing global health concern associated with numerous metabolic disorders. Traditional Ayurvedic medicine offers several remedies, among which Pippali Mool (root of Piper longum Linn) is noted for its Lekhana (scraping), Medohara (fat-reducing), and Deepana (digestive) properties.
This randomised control study aims to evaluate the clinical efficacy of Pippali Mool Arka (distilled extract) in managing Sthaulya. Participants diagnosed with obesity are randomly divided into two groups: one receiving Pippali Mool Arka and the other receiving no treatment. The study measures parameters like weight reduction, BMI, waist-hip ratio and subjective symptoms (e.g., lethargy, excessive appetite) over a fixed period.
The expected outcome is that Pippali Mool Arka will show statistically significant improvement in managing Sthaulya, validating its traditional use and suggesting its potential for broader therapeutic application.
 
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