FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2016/01/006494 [Registered on: 07/01/2016] Trial Registered Prospectively
Last Modified On: 11/12/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A comparative Clinical Study to evaluate the safety and efficacy of polyherbal formulation in high lipid level and overweight population. 
Scientific Title of Study   A Three Arm, Randomized, Open Label, Active-Controlled, Clinical Study to Evaluate Efficacy and Safety of Saunfbhara (PP/JLN/105) in the Management of Dyslipidemia & Body Weight 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Meenakshi Rewedkar 
Designation  Lecturer 
Affiliation  R A Podar Medical College (Ayu) & M.A. Podar Hospital 
Address  Department of Kayachikitsa, R A Podar Medical College (Ayu) & M.A. Podar Hospital Worli

Mumbai
MAHARASHTRA
400018
India 
Phone  09757476325  
Fax    
Email  minirewdkar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arun Gupta 
Designation  Head Medical Affairs & Clinical Research 
Affiliation  Dabur India Limited 
Address  Dabur Research & Development Centre, Dabur India Ltd, Plot No.22, Site IV, Sahibabad

Ghaziabad
UTTAR PRADESH
201010
India 
Phone  01203378614  
Fax  01204552645  
Email  arun.gupta@dabur.com  
 
Details of Contact Person
Public Query  
Name  Dr Sanjay Tamoli 
Designation  Director 
Affiliation  Target Institute of Medical Education & Research 
Address  Target Institute of Medical Education & Research,205 B Wing,Blue Diamond Society, Nayagoan Dahisar(West)
Mumbai
Mumbai
MAHARASHTRA
400068
India 
Phone  09322522252  
Fax    
Email  targetinstitute@yahoo.com  
 
Source of Monetary or Material Support  
Dabur India Limited 
 
Primary Sponsor  
Name  Dabur India Limited 
Address  Dabur Research and Development Centre Dabur India Limited Plot No.22 Site IV Sahibabad, Ghaziabad 
Type of Sponsor  Other [FMCG] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Meenakshi Rewedkar Kole   Department of Kayachikitsa, R A Podar Medical College (Ayu) & M.A. Podar Hospital  Department of Kayachikitsa, R A Podar Medical College (Ayu) & M.A. Podar Hospital Worli
Mumbai
MAHARASHTRA 		 09757476325

minirewdkar@gmail.com 
Dr Rajan Kulkarni   Department of Kayachikitsa, Ayurved Seva Sangh   Department of Kayachikitsa, Ayurved Seva Sangh Nashik, Ganeshwadi
Nashik
MAHARASHTRA 		 09420830818

vaidyarajankulkarni@yahoo.com 
Dr Paresh Kataria  Department of Panchkarma  D. Y Patil University, School of Ayurveda, Nerul,
Mumbai
MAHARASHTRA 		 8652182785

drpareshk3@gmail.com 
Dr Sagar More   Dept of Kayachikitsa, MAMS Sumatibhai Shah Ayurved Mahavidyalaya and Saneguruji Aarogya Kendra  Dept of Kayachikitsa, MAMS Sumatibhai Shah Ayurved Mahavidyalaya and Saneguruji Aarogya Kendra, Malwadi, Hadapsar
Pune
MAHARASHTRA 		 09822529950

drvaishalid@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Institutional Ethics Committee Ayurved Seva Sangh Nashik  Approved 
Institutional Ethics Committee R A Podar Medical College (Ayu)  Approved 
Institutional Ethics Committee, School of Ayurveda, D.Y Patil University  Approved 
Institutional Review Board for Research, MAMS Sumatibhai Shah Ayurved Mahavidyalaya and Saneguruji Aarogya Kendra  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E663||Overweight, (2) ICD-10 Condition: E789||Disorder of lipoprotein metabolism, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Guggulu  Marketed Guggulu will be given 1 capsule twice daily orally for 12 weeks. 
Intervention  Saunfbhara  Saunfbhara (Current studied product) is a polyherbal liquid/Capsule like preparation will be given 1-2 capsule twice daily orally for 12 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  •Subjects of either sex (Male and Female) in the age group of 18 to 65 years, both inclusive.
•Subjects with LDL-C greater or equal than 130 at the time of screening.
•Subjects with BMI greater or equal than 25
•Subjects willing to follow the procedures as per the study protocol and voluntarily give written informed consent.
 
 
ExclusionCriteria 
Details  •Subjects with Diabetes Mellitus Type I and uncontrolled Diabetes Mellitus Type II
•Subjects who have Diet with excess cholesterol, saturated fat or calories
•Subjects with uncontrolled Hypothyroidism or Hyperthyroidism
•Known cases of Severe/Chronic Hepatic or Renal disease
•Known subject of any active malignancy.
•Subjects giving history of significant cardiovascular event < 12 weeks prior to randomization.
•Known case of Anorexia Nervosa or Bulimia nervosa
•Chronic alcoholics / Alcohol Abuse
•Subjects ECG demonstrating any signs of uncontrolled arrhythmia / acute ischemia.
•Subjects X- ray chest showing any active lesion of tuberculosis
•Subjects having known chronic, contagious infectious disease, such as active tuberculosis Hepatitis B or C, or HIV.
•Subjects using any other investigational drug within 1 month prior to recruitment
•Known hypersensitivity to any of the ingredients used in study drug
•Pregnant and Lactating females.
•Subjects currently participating in any other Clinical study
•Any other medical or surgical condition considered unsuitable for subject participation in the study as per Investigator’s judgment
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Change in LDL-C level at the end of study (12 weeks)
2. Change in body weight at the end of study (12 weeks)
 		 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Change in LDL-C level at 6 weeks,Change in other lipid parameters such as Triglycerides (TG), Total Cholesterol (TC), High Density Lipoprotein (HDL), Body Weight, BMI, Waist circumference, Waist to hip ratio and EQ-5D Quality of Life (QOL) at 6 weeks and 12 weeks, Overall efficacy and safety of the study product as per the physician (CGI-I) at the end of study (12 weeks),Safety assessment by assessing adverse drug reactions, clinically significant abnormal laboratories values  6 and 12 weeks 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/01/2016 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Adult subjects of either sex with age between 18-65 years (both inclusive) will be screened for eligibility criteria.  Assessment of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. Subject’s Prakruti evaluation will be done. If the subject meets the inclusion and exclusion criteria subject he/she will be randomized as per computer generated randomization list. Subject will be assigned to either of the three study groups. Subject will be asked to take the assigned study product in the respective dose for a period of 12 weeks. Subjects will be asked to follow up after every 3 weeks   At the end of the study, all subjects will undergo Laboratory investigations and ECG. Physician’s overall assessment of efficacy and safety will be done at the end of the study. Subject’s clinical examinations including vitals like Pulse, Respiration, Temperature and Blood Pressure  will be checked at baseline and thereafter every follow up visit. Adverse events will be recorded throughout the study.  
Close