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CTRI Number  CTRI/2024/07/071509 [Registered on: 29/07/2024] Trial Registered Prospectively
Last Modified On: 07/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the effect of patol amalaki churna and yava amalaki churna in the patients of obesity 
Scientific Title of Study   Comparative study of the effect of patol amalaki churna and yava amalaki churna in sthaulya with special reference to obesity 
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 Vaishnavi VijayKumar Zawar  
Designation  PG Scholar  
Affiliation  SMBT ayurved college and hospital  
Address  Department of Kayachikitsa SMBT ayurved college and hospital, Nandi Hills, Dhamangaon,Nashik

Nashik
MAHARASHTRA
422403
India 
Phone  9975655490  
Fax    
Email  vaishnavizawar.vz@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ankush Haushiram Gunjal  
Designation  Associate Professor  
Affiliation  SMBT ayurved college and hospital  
Address  Department of Kayachikitsa SMBT ayurved college and hospital, Nandi Hills, Dhamangaon,Nashik

Nashik
MAHARASHTRA
422403
India 
Phone  7359117691  
Fax    
Email  dr.ankush30@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ankush Haushiram Gunjal  
Designation  Associate Professor  
Affiliation  SMBT ayurved college and hospital  
Address  Department of Kayachikitsa SMBT ayurved college and hospital, Nandi Hills, Dhamangaon,Nashik

Nashik
MAHARASHTRA
422403
India 
Phone  7359117691  
Fax    
Email  dr.ankush30@gmail.com  
 
Source of Monetary or Material Support  
Department of Kayachikitsa SMBT ayurved college and hospital Nandi Hills Dhamangaon Nashik Maharashtra India Postalcode 422403 
 
Primary Sponsor  
Name  Dr Vaishnavi VijayKumar Zawar  
Address  Department of Kayachikitsa SMBT ayurved college and hospital Nandi Hills Dhamangaon Nashik Maharashtra India Postalcode 422403 
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 Vaishnavi VijayKumar Zawar   SMBT ayurved college and hospital   OPD No10 Department of Kayachikitsa SMBT ayurved college and hospital
Nashik
MAHARASHTRA 		 9975655490

vaishnavizawar.vz@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMBT ayurved college and hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E660||Obesity due to excess calories. Ayurveda Condition: ATISTHAULYAM (KEVALA-KAPHA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: YAVA AMALAKI CHURNA, Reference: चरक सूत्रस्थान 21/23, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Koshnjal), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: PATOL AMALAKI CHURNA, Reference: चरक सूत्रस्थान 21/26, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Koshnjal), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.The patient having age between 18 years to 60 years and irrespective of
socioeconomic status, sex and religion.
2.Patient having signs and symptoms of obesity mentioned in Ayurvedic classics
like Swedadhikya, Kshudraswasa, Chalsphikaudarstanalumban, Atiskhudha,
Angagaurav, Angachalatva, Avyavaya, Atipipasa.
3.The patient of Obese class I (30.0-34.9 kg/m2) and Obese class II (35.0-39.9
kg/m2)
4.Patients having dyslipidaemia in their lipid profile results. 
 
ExclusionCriteria 
Details  1.The patient having Uncontrolled Hypertension, Cardiovascular disease,
pregnant women and will be excluded.
2.The patient of Obese class III (More than 40 kg/m2) will also be excluded.
3.Patients having serious cardiac, pulmonary, renal and hepatic disease etc.
4.Obesity and Hyperlipidemia due to drugs e.g. Anticonvulsant, Beta
blockers, Corticosteroid and Diuretics.
5.Patient having history of metabolic disorders like Diabetes mellitus, etc
and other Endocrine diseases. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Assessment will be done based on subjective and objective criteria
Subjective criteria is
Alasya,Kshudrashwasa,Swedadhikya,Daurbalyata,Atikshudha ,Daurgandhya
will be assessed based on gradation before and after treatment.
Objective criteria is
1.Weight
2.BMI:Body Mass Index
3.Waist to Hip Ratio
4.Lipid profile which will be assessed before and after treatment 		 After 45 days 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   15/08/2024 
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)   Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

     In today’s world, sedentary lifestyle, faulty dietary habits including ready to eat fast food and relatively less exercise and stress have made man the victim of many diseases.

     Sthaulya is one of these diseases, in which there is an abnormal and excessive accumulation of Medodhatu. In medical science, Sthaulya can be compared with obesity. Obesity is one of the world’s oldest metabolic disorders. The prevalence rate of sthaulya is 16.6%.

     Patol amalaki churna has been selected as a trial group A and Yava amalaki churna has been selected as a trial group B which breakdown the pathophysiology of sthaulya.

    The patients within the age group of 18 to 60 years who fulfilled the clinical diagnostic criteria and had symptoms of sthaulya as mentioned in classics were selected irrespective of sex, socio – economic status and community. Written consent from patient were taken prior to the study. Computerised generated sampling technique for randomisation was used. Total 80 number of patients were selected and divided into two groups, named as trial group A (40) and trial group B (40) in which 51 patients study was completed and remaining patients study is ongoing.

     Both Patol amalaki churna (trial group A) and Yava amalaki churna (trial group B) with dose 5 gm BD with anupana koshana jaal was administered to patients and observations were done on day 0, day 14, day 28, day 45 and after 56th day.

    Patient enrolment in progress. Discussion, summery and conclusion will be done after statistical analysis on completion of study and will be unbiased.


 
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