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CTRI Number  CTRI/2018/04/013224 [Registered on: 12/04/2018] Trial Registered Prospectively
Last Modified On: 04/01/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Herbaceutical]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical Study on Decrin Plus for Weight Reduction and Management 
Scientific Title of Study   A Double Blind, Prospective, Randomised, Comparative, Placebo Controlled, Two Arm Study to Evaluate the Efficacy, Safety and Tolerability of Decrin Plus in Obesity Reduction and Weight Management in Adults. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
AHC/MET/041/17 Ver 02 Dated 31-Jan-18  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr VTSriraam 
Designation  Investigator 
Affiliation  Aurous HealthCare Research and Development India Pvt Ltd 
Address  Research & Development Department, 180/109, G1&G2, RR Villa, Kodambakkam, Chennai

Chennai
TAMIL NADU
600024
India 
Phone  9840909155  
Fax    
Email  md@auroushealthcare.com  
 
Details of Contact Person
Scientific Query  
Name  Dr VTSriraam 
Designation  Investigator 
Affiliation  Aurous HealthCare Research and Development India Pvt Ltd 
Address  Research & Development Department, 180/109, G1&G2, RR Villa, Kodambakkam, Chennai

Chennai
TAMIL NADU
600024
India 
Phone  9840909155  
Fax    
Email  md@auroushealthcare.com  
 
Details of Contact Person
Public Query  
Name  Dr VTSriraam 
Designation  Investigator 
Affiliation  Aurous HealthCare Research and Development India Pvt Ltd 
Address  Research & Development Department, 180/109, G1&G2, RR Villa, Kodambakkam, Chennai

Chennai
TAMIL NADU
600024
India 
Phone  9840909155  
Fax    
Email  md@auroushealthcare.com  
 
Source of Monetary or Material Support  
Solar Herbo Private Limited 
 
Primary Sponsor  
Name  Solar Herbo Private Limited 
Address  A-6, 3rd Floor, Sterling Tower, Gavat Mandai, Shahupuri,Kolhapur - 416001 ,Maharashtra. India. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Aurous HealthCare Research and Development India Private Limited  #180/109, G1&G2, RR Villa, Rangarajapuram Main Road, Kodambakkam, Chennai - 600024 Tamil Nadu. India. 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr VT Sriraam  Raam Clinic  Research & Development Department, 180/109, G1&G2, RR Villa, Kodambakkam, Chennai 600024 Tamil Nadu. India.
Chennai
TAMIL NADU 		 9840909155

md@auroushealthcare.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Universal Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E660||Obesity due to excess calories,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Decrin Plus  Intended for treatment of obesity, Dosage: 2 capsules, twice a day for 3 months 
Comparator Agent  Placebo  No effect Dosage: 2 capsules, twice a day for 3 months 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Adult subjects between the ages of 21 and 65 years of age (both ages and sexes inclusive)
2. Subjects with BMI ≥30 kg/m2 and/or elevated lipid levels at the time of screening. (Subjects with elevated lipid levels to be considered as a separate cohort)
3. Subjects with normal gastrointestinal digestion and absorption.
4. Subjects who are non-alcoholic & non-smokers or have maintained complete abstinence for 2 months prior to screening and willing to abstain until end of treatment duration.
5. Subject/LAR who is willing to give informed consent for participation, able to comprehend and understand the responsibilities during treatment period and follow up period.
6. Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
 
 
ExclusionCriteria 
Details  1. Subjects with known hypersensitivity to herbal investigational product or its constituents.
2. Subjects with secondary obesity.
3. Subjects who have previously undergone surgery for the treatment of obesity not limited to liposuction, bariatric surgery etc.
4. Subjects with history of eating disorders.
5. Subjects with untreated or uncontrolled hypothyroidism.
6. Subjects who are currently on concomitant medications that may contribute to significant weight gain or weight loss.
7. Subjects with history of Acute Coronary syndrome, myocardial infarction, stroke, arrhythmia or atrial fibrillation in the past 1 year.
8. Subjects with poorly controlled hypertension.
9. Subjects with immune compromised state complications.
10. Subjects with uncontrolled diabetes, hypertension or congestive heart failure.
11. Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc.), any medical condition that is unstable/poorly controlled or other factor (e.g., planned relocation) that the Investigator felt would interfere with study evaluations and study participation.
12. Females who are pregnant or lactating or planning to become pregnant during the study period.
13. Females who have given birth or undergone a miscarriage in the past 1 year.
14. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
15. Subjects, who in the opinion of the Investigator or the Medical Experts are not eligible for enrolment in the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Anthropometric Changes: Reduction by ≥10% in Weight, BMI, Waist Circumference, Waist:Hip Ratio
2. Lipid Levels:s
a. LDL: Reduction of 10%
b. Total Cholesterol: Reduction of 10%
c. HDL: ≤60mg/dL
d. Triglycerides: Reduction of 10%
3. Subject Self Assessment Questionnaire: Score of ≥20
4. Subject IP Feedback Questionnaire: Score of ≥20 		 1. Anthropometric Changes: Day1, Day 30, Day 45, Day 90
2. Lipid Level: Day1, Day 45 and Day 90.
3. Subject Self Assessment Questionnaire: Day1, Day 30, Day 45, Day 90
4. Subject IP Feedback Questionnaire: Day 30, Day 45, Day 90 
 
Secondary Outcome  
Outcome  TimePoints 
1. Anthropometric Changes: Reduction by 5-9% in Weight, BMI, Waist Circumference, Waist:Hip Ratio
2. Lipid Levels:
a. LDL: Reduction of 5-9%
b. Total Cholesterol: Reduction of 5-9%
c. HDL: 40-49 mg/dL
d. Triglycerides: Reduction of 5-9%
3. Subject Self Assessment Questionnaire: Score of 15-19
4. Subject IP Feedback Questionnaire: Score of 15-19  		 1. Anthropometric Changes: Day1, Day 30, Day 45, Day 90
2. Lipid Level: Day1, Day 45 and Day 90.
3. Subject Self Assessment Questionnaire: Day1, Day 30, Day 45, Day 90
4. Subject IP Feedback Questionnaire: Day 30, Day 45, Day 90 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   30/04/2018 
Date of Study Completion (India) 01/10/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

Study Design: A Double Blind, Prospective, Randomized, Comparative, Parallel Group, Placebo Controlled, Two Arm Clinical Study Trial

Study Population: Adults between 21 and 65 years of age with BMI≥ 30 Kg/m2.(both ages and sexes inclusive)  

Indication : Obesity/weight Management

  • Investigational Product – Test  : Decrin plus
  • Investigational Product – Comparator :  Placebo.

 Study Duration :3 months

 Number of Subjects :  42 Subjects (To reach 36 evaluable subjects)

  •  Two Treatment Arms (2:1 Ratio)
  •  Treatment Arm I – Decrin Plus– 28 Subjects
  •  Treatment Arm II – Placebo – 14 Subjects.

 Assessments

  • 1. Anthropometric Measurements
  • 2. Laboratory Assessments(Lipid profile)
  • 3. Subject Self Assessment Questionnaire
  • 4. Subject IP Feed Back Questionnaire

Study Results

Weight Reduction: The data analysed confirms that 100% subjects in Decrin Plus group have achieved at least 10% reduction in Weight by end of study; while compared to 0% subjects in Placebo group. (Z = 6.00, p < 0.05).

Reduction in BMI:  The data analysed confirms that 96% of the subjects in Decrin Plus group have achieved at least 10% reduction in BMI by end of study; while compared to 0% subjects in Placebo group (Z = 5.63, p < 0.05)

Reduction in Waist Circumference: The data analysed confirms that 100% of the subjects in Decrin Plus group have achieved at least 10% reduction in Waist Circumference by end of study; while compared to 0% subjects in Placebo group (Z = 6.00, p < 0.05).

Reduction in Waist:Hip Ratio: The data analysed confirms that 80% of the subjects in Decrin Plus group have achieved at least 10% reduction in Waist : Hip Ratio by end of study; while compared to 0% subjects in Placebo group (Z = 4.45, p < 0.05).

Safety Results: No adverse event was reported by any subject enrolled into the study.

Study Conclusion:  Overall, it is concluded that Decrin Plus was very effective in significantly reducing Weight, BMI, Waist Circumference and Wasit: Hip Ratio.  100% of the subjects who took Decrin Plus assessed it to be effective in reducing their weight and improving their quality of life.  There was no adverse events recorded upon the consumption of Decrin Plus.  

Decrin Plus is recommended as a safe and effective therapy for Weight Reduction and Obesity Management in Adults. 

 

 

 

 
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