| CTRI Number |
CTRI/2025/08/093439 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
11/08/2025 |
| 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 Effect and Safety of Feiolix Capsules in Prediabetic Participants. |
|
Scientific Title of Study
|
A Single Center, Randomized, Double Blind, Placebo Controlled, Interventional, Comparative, Clinical Study to evaluate the Efficacy and Safety of Feiolix Capsules in Prediabetic Participants. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BCR-VIR-005 Version - 1.0 Dated 14 Jul 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashish Sarwate |
| Designation |
Principal Investigator |
| Affiliation |
Dr. Sarwates Diabetes Control and Foot Care Centre |
| Address |
Dr. Sarwates Diabetes Control and Foot Care Centre, 004 Gohit, Ground floor, Kanchanpushpa Complex, Opp. Dena Bank, Near Suraj Water Park, Ghodbunder Road, Thane West, Maharashtra, India.
Thane
MAHARASHTRA
400615
India |
| Phone |
9833259022 |
| Fax |
|
| Email |
ashish.sarwate@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeta Nargundkar |
| Designation |
Managing Director |
| Affiliation |
Biosphere Clinical Research Pvt Ltd |
| Address |
SB-02, 03 and 04, Second Floor Highland Corporate Centre, Kapurbawdi Junction, Thane West Maharashtra, India
Thane
MAHARASHTRA
400607
India |
| Phone |
02241006794 |
| Fax |
|
| Email |
drneeta@biospherecro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neeta Nargundkar |
| Designation |
Managing Director |
| Affiliation |
Biosphere Clinical Research Pvt Ltd |
| Address |
SB-02, 03 and 04, Second Floor Highland Corporate Centre, Kapurbawdi Junction, Thane West Maharashtra, India
Thane
MAHARASHTRA
400607
India |
| Phone |
02241006794 |
| Fax |
|
| Email |
drneeta@biospherecro.com |
|
|
Source of Monetary or Material Support
|
| Viridis BioPharma Pvt Ltd,
6/10, Jogani Industrial Complex,
V.N. Purav Marg, Chunabhatti,
Mumbai, Maharashtra 400022
India
|
|
|
Primary Sponsor
|
| Name |
Viridis BioPharma Pvt. Ltd. |
| Address |
6/10, Jogani Industrial Complex, V.N. Purav Marg, Chunabhatti, Mumbai, Maharashtra 400022, India
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashish Sarwate |
Dr. Sarwates Diabetes Control and Foot Care Centre |
Dr. Sarwates Diabetes Control and Foot Care Centre, 004 Gohit, Ground floor, Kanchanpushpa Complex, Opp. Dena Bank, Near Suraj Water Park, Ghodbunder Road, Thane (West), Maharashtra, India.
Thane
MAHARASHTRA |
9833259022
ashish.sarwate@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethicare Ethics Committee Ethicare Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R730||Abnormal glucose, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Feiolix Capsule 287.5 mg (4 Feiolix capsules = 1150 mg)
|
Four capsules to be taken with water, once a day, orally 5 minutes before breakfast for 90 days |
| Intervention |
Feiolix Capsule 300 mg + Placebo Capsules (1 capsule of Feiolix and 3 capsules of Placebo) |
Four capsules to be taken with water, once a day, orally 5 minutes before breakfast for 90 days |
| Comparator Agent |
Placebo Capsule [adjusted to energy content of the test] (4 Placebo capsules) |
Four capsules to be taken with water, once a day, orally 5 minutes before breakfast for 90 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult male and female participants, 20 to 65 years of age (both inclusive).
2. Participants with BMI greater than or equal to 25.00 and less than or equal to 29.9 kg/m2 at screening (overweight).
3. Participants with Glycosylated Hemoglobin (HbA1c) greater than or equal to 5.7 % and less than or equal to 6.4%.
4. Participants whose IDRS (Indian Diabetics Risk score) is less than or equal to 60.
5. Participants who are willing to give informed consent for participation in the study and willing to adhere to all protocol procedures.
|
|
| ExclusionCriteria |
| Details |
1. Participants with a known history of hypersensitivity to the study medication or any of the ingredients of the formulation.
2. Participants with type 1 or type 2 Diabetes mellitus (T2DM), gestational diabetes or secondary diabetes.
3. Participants on treatment with a glucose-lowering or weight loss agent (s) within 90 days before screening.
4. Participants with hypothyroidism or hyperthyroidism.
5. Participants with elevated liver enzymes AST and/or ALT more than 3 times the upper normal limit.
6. Participants with abnormal renal function as measured by eGFR less than 60 ml/min/1.73m2.
7. Participants who had bariatric surgery.
8. Participants with a significant change in usual diet and/or weight loss of more than 4.5 kg in the last 2 months.
9. Participants with a known history of chronic smoking, alcohol or drug abuse within the 12 months prior to screening.
10. Participants with a known history or ongoing malignancy.
11. Participants with the treatment of immunosuppressive medications in past three months.
12. Participants with any other co-morbidities necessitating medical care.
13. Participants who have undergone surgery in the last 6 months including but not limited to angioplasty, abdominal surgeries (including weight loss surgery) or partial/complete resection of stomach or bowel.
14. Participants with the presence or history of psychiatric illnesses, including eating disorders.
15. Participants with a family history of obesity.
16. Participants using phytoherbal supplements, dietary, nutraceuticals, allopathic, or ayurvedic supplements for weight loss or blood glucose management, supplements known to affect hunger/satiety/appetite/gut microbiome.
17. Any other health or mental condition or any significant laboratory parameters that in the investigators opinion may adversely affect the participants ability to complete the study or its measures or that may pose significant risk to the participant.
18. Female participants who are pregnant or lactating or planning to become pregnant during the study period. Females or males who are not ready to use acceptable contraceptive methods during the course of study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean change in Glycosylated hemoglobin (HbA1c) from baseline to Visit 5/Day 90±3.
Mean change in appetite regulatory hormone [Glucagon-like peptide 1(GLP-1)] in fasting and post standardized breakfast – 30 minutes, 1 hour and 2 hours from Visit 2/Day 1 to Visit 5/Day 90±3. |
90 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in blood sugar levels in fasting and post standardized breakfast – 30 minutes, 1 hour and 2 hours from Visit 2/Day 1 to Visit 5/Day 90±3. |
90 Days |
| Mean change in appetite regulatory hormone (Glucagon and Ghrelin) in fasting and post standardized breakfast – 30 minutes, 1 hour and 2 hours from Visit 2/Day 1 to Visit 5/Day 90±3. |
90 Days |
| Mean change in insulin resistance (Insulin) in fasting and post standardized breakfast – 30 minutes, 1 hour and 2 hours from Visit 2/Day 1 to Visit 5/Day 90±3. |
90 Days |
| Mean change in insulin resistance (HOMA IR score) in fasting from Visit 2/Day 1 to Visit 5/Day 90±3. |
90 Days |
| Mean change in fat metabolism (Lipid Profile) in fasting from Visit 2/Day 1 to Visit 5/Day 90±3. |
90 Days |
| Mean change in anthropometric parameters (Body Weight, BMI and Waist Circumference) from baseline to Visit 3/Day 30±3, Visit 4/Day 60±3 and Visit 5/Day 90±3. |
90 Days |
| Mean change in satiety (Visual Analog Scale for Satiety Assessment) post standardized breakfast – 30 minutes, 1 hour, 2 hours and 3 hours from Visit 2/Day 1 to Visit 5/Day 90±3. |
90 Days |
Safety Endpoint:
The assessment of safety of Investigational Product will be based on incidence of AEs, SAEs and changes in laboratory parameters.
|
90 Days |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
03/09/2025 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
A Single Center, Randomized, Double Blind, Placebo Controlled, Interventional, Comparative, Clinical Study to evaluate the Efficacy and Safety of Feiolix Capsules in Prediabetic Participants. |