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CTRI Number  CTRI/2023/10/058642 [Registered on: 13/10/2023] Trial Registered Prospectively
Last Modified On: 11/11/2025
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 study the efficacy and safety of root extract (Coleus forskohlii) for weight reduction and break down of fat in over-weight patients.  
Scientific Title of Study   A randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy and safety of ForsLean® for weight reduction and energy balance in overweight patients. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanjana Kumari V T 
Designation  Principal Investigator 
Affiliation  Sri Laxmi Hospital 
Address  Department of General Medicine Room No 2 Ground Floor Opposite to Velankani road Doddathogur Village Electronics City

Bangalore
KARNATAKA
560100
India 
Phone  09483727956  
Fax    
Email  dr.sanjanalaxmi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Satish G 
Designation  Vice President 
Affiliation  Sami Sabinsa Group Limited 
Address  Department of Clinical Research First Floor 19/1 and 19/2 I Main II Phase Peenya Industrial Area

Bangalore
KARNATAKA
560058
India 
Phone  08068527777  
Fax    
Email  satish.g@sami-sabinsagroup.com  
 
Details of Contact Person
Public Query  
Name  Satish G 
Designation  Vice President 
Affiliation  Sami Sabinsa Group Limited 
Address  Department of Clinical Research First Floor 19/1 and 19/2 I Main II Phase Peenya Industrial Area

Bangalore
KARNATAKA
560058
India 
Phone  08068527777  
Fax    
Email  satish.g@sami-sabinsagroup.com  
 
Source of Monetary or Material Support  
Sami-Sabinsa Group Limited 19/1 19/2 I Main II Phase Peenya Industrial Area Bengaluru- 560058 
 
Primary Sponsor  
Name  Sami-Sabinsa Group Limited 
Address  19/1 and 19/2, I Main, II Phase, Peenya Industrial Area Bangalore 
Type of Sponsor  Other [Manufactures and markets phytonutrients, standardized herbal extracts and nutritional supplements.] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Parashuram  Dr. BRAmbedkar Medical College and Hospital  No48,Indrajit swamy Layout, Shampur Main Road, Bangalore560045
Bangalore
KARNATAKA 		 9986311450

drbhavimani@gmail.com 
Dr Sanjana Kumari V T  Sri Laxmi Hospital  # 50, Ground Floor, Room No. 2, Opposite to Velankani road, Doddathogur Village, Electronics City, Bangalore-560100
Bangalore
KARNATAKA 		 9483727956

dr.sanjanalaxmi@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
ACE Independent Ethics Committee  Approved 
Institutional Ethics CommitteeDr,BRAmbedkar Medical college Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Over-weight 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Forslean  250mg Capsule- Twice a day, 30 mins before breakfast and dinner for 90 days. 
Comparator Agent  Microcrystalline Cellulose  250mg Capsule- Twice a day, 30 mins before breakfast and dinner for 90 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Male and Female participants whose age ≥18 and ≤ 50 years.
2. Participants must provide written and signed informed consent and comply with the requirements of the study.
3. Must be able to swallow oral medications for 90 days on a daily basis and comply with the study requirements as per the protocol.
4. Participants with a BMI of ≥ 25 to ≤ 29.9.
5. Self-reported lack of physical activity and lethargic lifestyle.
6. Participants who are willing to take up walking exercise for a span of 30 minutes daily for 5 days a week.
7. Participants who are willing to follow the recommended calorie intake of 2000 for women & 2500 for men throughout the study. 
 
ExclusionCriteria 
Details  1. Intake of over the counter or prescribed Allopathic/Ayurvedic/ Homeopathic/Naturopathic weight loss medications, centrally acting appetite suppressants in the past three months.
2. Previous weight loss surgeries like bariatric surgery procedures (gastric bypass, sleeve gastrectomy, adjustable gastric band, biliopancreatic diversion with duodenal switch etc.)
3. On other modulators like special diet, diet control, gym, and yoga.
4. Pathophysiologic/genetic syndromes associated with obesity (Cushing’s syndrome, Turner’s syndrome, Prader-Willi syndrome).
5. History of chronic smoking (more than 2 cigarettes a day)
6. Alcoholics (Inability to control drinking due to both physical & emotional dependence on alcohol characterized by uncontrolled drinking & preoccupation with alcohol).
7. Patients with evidence of malignancy
8. Patients with diabetes (Type I or Type II), FBS ≥ 126 mg/dl and HbA1c > 6.5%
9. Patients with Hypertension having BP > 140 / 90 mm of Hg.
10. Patients diagnosed with thyroid disease, on medications for underactive or overactive thyroid and with TSH > 6 µIU/L
11. Patients on lipid lowering drugs.
12. Patients having history of underlying inflammatory arthropathy, septic arthritis, inflammatory joint disease, gout, pseudo gout, Paget’s disease, joint fracture, acromegaly, fibromyalgia, Wilsons disease, Ochronosis, hemochromatosis, heritable arthritic disorder or collagen gene mutations or rheumatoid arthritis.
13. Patients having history of coagulopathies, cardiovascular diseases, congestive heart failure, pancreatitis, lactic acidosis, hepatomegaly with steatosis, motor weakness, peripheral sensory neuropathy, psychiatric disorder, Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD].
14. Have been diagnosed with an eating disorder, such as anorexia, bulimia, binge eating disorder or nocturnal eating disorder.
15. History of severe psychiatric disorders like schizophrenia or bipolar disorder.
16. Weight loss (±5%) in last 6 months.
17. Patients on prolonged (> 4 weeks) medication with corticosteroids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study.
18. Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and/or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP)>2 times upper normal limit) or Renal Disorders (defined as S. Creatinine>1.2mg/dL for females or >1.4 mg/dL for males and EGFR <60).
19. History of hypersensitivity to any of the herbal extracts or dietary supplements.
20. Pregnant/lactating women and those not willing to follow a reliable and effective contraceptive measure during the study.
21. All females with history of PCOS (Poly Cystic Ovary Syndrome)
22. Those who have participated in any other clinical trial within three months from the screening.
23. Any other condition which the Principal Investigator thinks may jeopardize the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To assess mean change in body weight
2. To assess mean change in BMI
3. To assess mean change in waist circumference
4. To assess mean change in hip circumference 		 1. Screening to Day-90
2. Screening to Day-90
3. Screening to Day-90
4. Screening to Day-90 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess the change in lean body mass.
2. To assess mean change in Lipid profile
3. To assess change in visceral fats, subcutaneous fat, and total fat area using CT abdomen.
4. To assess change in biomarkers (Leptin & Adiponectin)
5. Self-reported improvement in physical activity, stamina and lifestyle based on quality of life. 		 1. Screening to Day-90
2. Screening to Day-90
3. Randomization and Day-90
4. Randomization and Day-90
5. Randomization to Day-90 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   30/10/2023 
Date of Study Completion (India) 16/07/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 The study involves 80 subjects randomized in to two arms. Arm-1 subjects will receive Forslean-250mg Capsule while Arm-2 Subjects will receive Placebo containing MCC-250 mg capsule. Both the groups will take the respective IPs b.i.d for 90 days, 30 minutes before food. A telephonic follow-up will be performed after 15 days following the last visit. The Specific objectives of the study will be measured using Anthropometric measurements, laboratory biomarkers (Leptin, Adiponectin, Lipid Profile and CT scan). A patient diary will be maintained to assess the food habits, physical activity and lifestyle based on calorie intake, energy expenditure and distribution of fats. The final statistical analysis and study report will be complied at the end of the study period. 
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