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CTRI Number  CTRI/2022/12/047896 [Registered on: 06/12/2022] Trial Registered Prospectively
Last Modified On: 09/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative clinical evaluation of trikatu churna and kalbhojanam in sthoulya. 
Scientific Title of Study   Comparative clinical evaluation of trikatu churna and kalbhojanam in sthoulya. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Priyanka Sharma 
Designation  Assistant Professor,Ph.D. Scholar 
Affiliation  Rishikul Campus,UAU,Haridwar 
Address  house no. 12,Adarsh Nagar,Haridwar
Rishikul campus haridwar Uttrakhand ayurveda University harrawala dehradun
Hardwar
UTTARANCHAL
249407
India 
Phone  7310626305  
Fax    
Email  drpriyanka.swasthavrita2022@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Avadhesh Kumar 
Designation  HOD Dept. Of Swasthavritta and Yoga 
Affiliation  Gurukul campus,UAU,Haridwar 
Address  Dwarikavihar,Haridwaar
Gurukul Campus,Gurukul Kangri,Haridwar
Hardwar
UTTARANCHAL
249404
India 
Phone  8630287151  
Fax    
Email  dr.avadheshmishra@gmail.com  
 
Details of Contact Person
Public Query  
Name  Avadhesh Kumar 
Designation  HOD Dept. Of Swasthavritta and Yoga 
Affiliation  Gurukul campus,UAU,Haridwar 
Address  Dwarikavihar,Haridwaar
Gurukul Campus,Gurukul Kangri,Haridwar
Hardwar
UTTARANCHAL
249404
India 
Phone  8630287151  
Fax    
Email  dr.avadheshmishra@gmail.com  
 
Source of Monetary or Material Support  
Rishikul Campus,U.A.U.,Haridwar,Uttarakhand 
 
Primary Sponsor  
Name  Priyanka Sharma 
Address  Rishikul Campus,U.A.U.,Haridwar,Uttarakhand 
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 
Priyanka Sharma  Rishikul campus haridwar Uttarakhand ayurveda University   Dept of Swasthavritta OPD no 2 Rishikul campus haridwar Uttarakhand ayurveda University
Hardwar
UTTARANCHAL 		 7310626305

drpriyanka.swasthavrita2022@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: sthoulya, (2) ICD-10 Condition:E663||Overweight. Ayurveda Condition: Sthoulya ,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmLifestyle--Dinacarya: Kalbhojanam , Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:, Pathya:, Apathya:
2Comparator ArmDrugClassical(1) Medicine Name: Trikatu churna , Reference: Charak samhita , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -ushna jala), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Patient willing to sign the consent form.2.The patients between the age group of 18 to 50 years of either sex presenting with
clinical features of Sthaulya (obesity).4. Patients having BMI more than or equal to 25Kg/m2.
 
 
ExclusionCriteria 
Details  1. Age below 18 and above 50 years.
2. Patients with complicated and chronic disorder like nephroticsyndrome,
hypothyroidism, jaundice, hepatitis, chronic infections andother serious diseases.
3. Patients having Obesity due to secondary causes such as druginduced or hormonal
imbalance like contraceptive pills.
4. Pregnant women and lactating mother.
5. Patients suffering from Diabetes mellitus .
6. Systemic illness like Tuberculosis, Carcinoma and Endocrinedisorders like Cushing
syndrome, Hypothyroidism.
7. Patient having the past history of M.I. & Unstable Angina.
8. Patient having Clinical Features of CCF.
9. Patient having the major renal or liver disorder. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Change in body weight.
2. Changes in BMI.
3. Changes in anthropometric parameters.
4. Changes in skin folds thickness.
5. Changes in lipid profile
 		 All measure in Time Frame: 30th day, 60th day, 90th day, 120th day. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Reduction in risk of type 2 diabetes mellitus Will be assessed by fasting blood sugar
level and Indian Diabetes Risk Score.
2. Reduction in risk of Coronaryarterydiseasewill be assessed by FRAMINGHMS 10
years cardiac risk score). 		 Time Framefor both: 30th day, 90th days and 120thth day 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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)   08/12/2022 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  		 3 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 Sthoulya is defined as excessive production of meda dhatu alongwith mamsa dhatu in the body. This excessive production of meda dhatu and mamsa dhatu results a person to malformed body with penduloussphika,udara and stana and having lack of enthusiasm.Sthoulya is not an acute onset disease infact long term Nidana sevana leads to it.frequent and excess intake food which increase the kapha and medo dhatu ,sedentary lifestyle,lack of mental and physical excercise are main causes of sthaulya apart from beeja dosha.Sthaulya in modern parlance is equated with obesity .The key causes of obesity are also same as sthaulya ,increased consumption of energy-dense food high in saturated fats and sugars and reduced physical activity.Obesity and over weight pose a major risk for chronic diseases,includin type-2 diabetes,cardiovascular disease,hypertension and stroke,and certain forms of cancer.Thus,mortality and morbidty rete were high in obese persons as compared to others.According to WHO in 2016,more than 1.9 billion adults worldwide (39%) were overweight,and over 650 million (13%) were obese.The current trajectory of prevalence acceleration would result in almost half of the world’s population being overweight or obese by 2030.Prevelance of obesity in India is 40.3%.Therefore,its high time for world to follow Ayurvedic principles which aims to preserve swatha primarily.Among a large number of dietary strategies described in Ayurvedic classics,for swastha kalabhojanam intake of food at a scheduled time,and not ad libitum,is suggested to be the best strategy to confer good health.Kalabhojanma is described in context of agryasangraha i.e., interventions and materials that are of principal significance for acheiving a particular objective.This clearly implies that assuming that one follows every guidance of Ayurveda to acheive good health,but compromises or ignores just the kalabhojanam,sustainable health span may remain acheivable.Kalabhojanam,therefore,is an indespensable component to confer arogya.Finally,treating sthoulya challenges is a global priority,so kalabhojanam should be considered additional to medicinal approach.A number of herbals and herbo-mineral medicines are described in various ancient text of ayurveda for treating Sthoulya.As per Ashtanga Hridyam has described Triakatu Churna in his treatise for Sthoulya which is having ingredients like Shunthi,Maricha and Pippali.These drugs having Ushna,Laghu,Ruksha Guna and Deepana,Kapha-Vatahara and Sthaoulyahara properties mentioned in literature.
पिप्पली मरिच शुण्ठी त्रिभि: त्र्यूषणमुच्यते । 
दीपनं श्लेष्म मेदोघ्न कुष्ठ पीनसनाशनं ॥
जयेदरोचकं सामं मेह गुल्म गलामयान ॥ 

 
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