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CTRI Number  CTRI/2023/03/051059 [Registered on: 27/03/2023] Trial Registered Prospectively
Last Modified On: 24/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of Navak Guggulu on obesity  
Scientific Title of Study   A Comparative Pharmacaceutico -Clinical study of Navak guggulu made by two different shodhana media on medoroga w.s.r to obesity  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ranjit kumar  
Designation  Pg Scholar 
Affiliation  Goverment Ayurvedic College,Patna  
Address  Department of Rasa shastra Government Ayurvedic College, Kadamkuan

Patna
BIHAR
800003
India 
Phone  8292474297  
Fax    
Email  drranjitras@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prabhat Kumar Dwivedi 
Designation  Professor Department Of Rasashastra  
Affiliation  Goverment Ayurvedic College,Patna  
Address  Pg Department of Rasa shastra Government Ayurvedic College, Kadamkuan

Patna
BIHAR
800003
India 
Phone  9431172175  
Fax    
Email  drprabhatkd@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Prabhat Kumar Dwivedi 
Designation  Professor Department Of Rasashastra  
Affiliation  Goverment Ayurvedic College,Patna  
Address  Pg Department of Rasa shastra Government Ayurvedic College, Kadamkuan

Patna
BIHAR
800003
India 
Phone  9431172175  
Fax    
Email  drprabhatkd@gmail.com  
 
Source of Monetary or Material Support  
Goverment Ayurvedic College, Patna  
 
Primary Sponsor  
Name  Goverment Ayurvedic College, Patna  
Address  Goverment Ayurvedic College, Kadamkuan,Patna 800003 
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 Ranjit Kumar  Government Ayurvedic College Hospital  PG Department of Rasa Shastra and Bhaishajya Kalpana OPD No 10 Government Ayurvedic college Kadamkuan, Budh murthi Patna Bihar 800003 Patna BIHAR
Patna
BIHAR 		 8292474297

drranjitras@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
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: Obesity,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Navak Guggulu shodhit by Triphala Kashay, Reference: Chakradutta-Pramehadhikar, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Ushna jala), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Navak Guggulu shodhit by gomutra, Reference: Chakradutta pramehadhikar, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -ushna jala), Additional Information: -
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients willing for the trial & able to participate for 3 months after consent.
A) Patients suffering from Medoroga
B) Patients suffering from Hyperlipidemia (Particularly high cholesterol & LDL)
or both will take part of this criteria.
BMI >26
Total cholesterol (mg/dl) ->200, LDL (mg/dl)->130, VLDL (mg/dl)- >35, Triglycerides->150 mg/dl
Patient’s age between 25-80 years
 
 
ExclusionCriteria 
Details  Medoroga due to endocrinal disorder like Hypothyroidism, Cushing syndrome etc.
Drug induced obesity and Hyperlipidemia such as long-term intake of OCP, Beta Blockers & Corticosteroids
Age below 25 and above 80 years.
Patients having complications like Renal Disease, Diabetes, Hypertension, Mental Disorder etc.
Patients having any other systemic illness. Like genetical disorder etc
Pregnancy & Breast Feeding
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Assessment of body weight of patient before and after treatment   90 days  
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of body weight of patient before and after treatment   15 days  
 
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   N/A 
Date of First Enrollment (India)   27/03/2023 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   No 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Obesity in India has reached epidemic proportions in the 21st century, with morbid obesity affecting 5% of the country’s population. India is following a trend of other developing countries that are steadily becoming more obese. Unhealthy, processed food has become much more accessible following India’s continued integration in global food markets. This, combined with rising middle-class incomes, is increasing the average caloric intake per individual among middle class and high-income households. Obesity is a major risk factor for cardiovascular disease, Sthaulya (The term used for obesity in ayurvedic text) has been included by Acharya Charak among “Ashtauninditiya Purusha”. (Ch.Su.21/21).  
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