FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/02/062285 [Registered on: 05/02/2024] Trial Registered Prospectively
Last Modified On: 14/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To evaluate the effects of fenugreek seed extract (INDUS810) in overweight females. 
Scientific Title of Study   A randomized, double-blind, placebo-controlled study of oral supplementation of low molecular weight galactomannan based standardized fenugreek seed extract (INDUS810) on fat mass in overweight females. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
INDUS810-W-ORAL-HFM version 1.0 Date 08 Nov 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Subhal Dixit 
Designation  Principal Investigator 
Affiliation  Sanjeevan Hospital 
Address  23 off karwe Road, kashibai khilare path, Erandwane Pune, Maharashtra

Pune
MAHARASHTRA
411004
India 
Phone  02067250000  
Fax    
Email  subhaldixit@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sornaraja Thasma 
Designation  Director Quality Assurance 
Affiliation  ProRelix Services LLP 
Address  ProRelix Services LLP, 102 A/B, Park Plaza, Main Karve Nagar Chowk, Karve Nagar, Pune, India, Maharashtra 411052 India

Pune
MAHARASHTRA
411052
India 
Phone  8124806366  
Fax    
Email  s.thasma@prorelixresearch.com  
 
Details of Contact Person
Public Query  
Name  Mr Sohal Pendse 
Designation  Director Business Operations 
Affiliation  ProRelix Services LLP 
Address  ProRelix Services LLP, 102 A/B, Park Plaza, Main Karve Nagar Chowk, Karve Nagar, Pune, India, Maharashtra 411052 India

Pune
MAHARASHTRA
411052
India 
Phone  9890096725  
Fax    
Email  s.pendse@prorelixresearch.com  
 
Source of Monetary or Material Support  
Indus Biotech Limited 1, Rahul Residency, Salunkhe Vihar Road, Kondhwa, Pune-411048, Maharashtra, India  
 
Primary Sponsor  
Name  Indus Biotech Limited 
Address  1, Rahul Residency, Salunkhe Vihar Road, Kondhwa, Pune-411048, Maharashtra, India 
Type of Sponsor  Other [Nutraceutical Industry - India] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Subhal Dixit  Sanjeevan Hospital  OPD 2, Department of Medicine, Diabetology division, 23 off karwe Road, kashibai khilare path, Erandwane Pune, Maharashtra.
Pune
MAHARASHTRA 		 02067250000

subhaldixit@gmail.com 
Dr Jitendra Agarwal  Suryaprabha Nursing Home  OPD 1, Department of Medicine, Diabetology division, Plot no. 7, Paud Road, Kothrud, Pune- 411038
Pune
MAHARASHTRA 		 8485841070

drambapkar.sourabh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Royal Pune Independent Ethics Committee  Approved 
Royal Pune Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Overweight 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  INDUS810 Capsules  two capsules to be taken once daily in the morning, before meal (empty stomach) for 12 weeks 
Comparator Agent  PLACEBO Capsules  No active pharmaceutical ingredient, two capsules to be taken once daily in the morning, before meal (empty stomach) for 12 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  1. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.2. Women with age between 18 to 60 years 3. Healthy females with body mass index (BMI) of 25 to 30 kg per m2 4. Willing to continue with their existing diet, exercise, and lifestyle habits throughout the study, without any change.5. Agree to avoid consuming any supplements meant for weight or fat loss during the study period. 
 
ExclusionCriteria 
Details  Participants meeting any of the following criteria will be excluded from the study:
1. Allergy or sensitivity to any ingredient of investigational product
2. Participation in any clinical study within 30 days before randomization.
3. Use of natural health products or dietary supplements within 7 days before randomization and during the study.
4. Pregnant or planning to be pregnant and lactating.
5. Any kind of substance abuse, (alcohol, tobacco, or any other substance).
6. Participant taking cholesterol lowering medications, for eg. Statins like atorvastatin, Fibrates like fenofibrate
7. Participant with a history of hyper or hypo thyroidism and currently taking hyper or hypo thyroid medicines.
8. Uncontrolled metabolic diseases or chronic diseases at the discretion of the investigator
9. Unstable medical conditions as determined by the qualified investigator.
10. Planned surgery during the trial; history of any surgery past 3 months.
11. Current diagnosis of immune-compromised conditions like HIV or AIDS, cancer
12. History of blood or bleeding disorders; blood donation in the previous 2 months.
13. Any other condition that in the qualified investigator’s opinion may have adversely affected the participant’s ability to complete the study or its measures or which may have posed a significant risk to the participant. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of INDUS810 oral supplementation (Capsules) on percent fat mass as measured by DEXA  Baseline, Week 6, Week 12 
 
Secondary Outcome  
Outcome  TimePoints 
A: Efficacy 1. Total body mass composition:Absolute fat mass,Lean mass,BMC,Fat-free mass,Body weight,Total tissue mass 2. Visceral adipose tissue Segmental body composition through tissue percent fat, region percent fat, tissue mass,fat mass,lean mass,BMC,total mass in Arms, Legs, Trunk, Android, Gynoid,Android to Gynoid ratio,Total,Fat mass ratio 4. Total BMD 5. Resting Metabolic Rate 6. Relative skeletal muscle mass index 7. Anthropometric measures:Waist circumference,Hip circumference,Waist-hip ratio,Abdominal girth 8. BMI 9. Fatty Liver Index 10. NAFLD liver fat score & fat percent 11. Dose and frequency of ongoing medication taken for fat mass related co-morbidities. 12. LFT 13. Lipid & carbohydrate metabolism parameters 14. Phenotypic Age 15. Physical activity: 6-MWT, 30-sec chair stand test 16. Quality of life:SF-36 B. Safety: 1. Clinical examination 2. Vital signs 3. hematology,KFT,urine analysis 4.Adverse events  Baseline, Week 6, Week 12 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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 
Date of First Enrollment (India)   08/02/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Suspended 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
One hundred and forty subjects of age 18- 60 will be assigned in 1:1 ratio to treatment with the test product, INDUS810 capsules or Placebo in this double- blind, randomized, placebo- controlled study. All 140 enrolled subjects will be instructed to take two capsules of INDUS810 capsules and Placebo, once daily in the morning, before meal (empty stomach) for 12 weeks. Subjects will be required to use diaries to document the date, time and dosage of study treatments including any missed doses and the occurrence of any adverse events. The efficacy of investigational product will be assessed primarily with DEXA Scan. Primary objective is to evaluate the efficacy of INDUS810 oral supplementation (Capsules) on percent (%) fat mass. High-fat mass (HFM) prevention is a critical factor in controlling related non-communicable diseases such as insulin resistance, metabolic syndrome, hyperinsulinemia, type 2 diabetes,hyperlipidemia, hypertension, and coronary artery disease. Low-molecular-weight galactomannan based standardized fenugreek seed extract (INDUS810) oral supplementation has shown efficacy against high fight mass and related health problems in previous preclinical and clinical trials.
 
Close