| CTRI Number |
CTRI/2021/08/036060 [Registered on: 31/08/2021] Trial Registered Prospectively |
| Last Modified On: |
30/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study of nutraceutical product in Patients |
|
Scientific Title of Study
|
A Randomized, Open label, Prospective, Three Arm, Parallel, Multicenter study to Evaluate Efficacy and Safety of Metformin with / without Concomitant Administration of Thymoquinone in Patients with Type 2 Diabetes Mellitus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 0242-21, Version 1.0, Dated 19 Jun 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prashant Modi |
| Designation |
Sr. General Manager |
| Affiliation |
Lambda Therapeutic Research Ltd. |
| Address |
Lambda house, Plot No. 38, Survey no. 388, Near Silver Oak Club, S. G. Highway, Gota
Ahmadabad
GUJARAT
382481
India |
| Phone |
07940202375 |
| Fax |
07940202021 |
| Email |
prashantmodi@lambda-cro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naman Shah |
| Designation |
Sr. General Manager |
| Affiliation |
Lambda Therapeutic Research Ltd. |
| Address |
Lambda house, Plot No. 38, Survey no. 388, Near Silver Oak Club, S. G. Highway, Gota
Ahmadabad
GUJARAT
382481
India |
| Phone |
07940202389 |
| Fax |
07940202021 |
| Email |
namanshah@lambda-cro.com |
|
Details of Contact Person
Public Query
|
| Name |
Prashant Modi |
| Designation |
Sr. General Manager |
| Affiliation |
Lambda Therapeutic Research Ltd. |
| Address |
Lambda house, Plot No. 38, Survey no. 388, Near Silver Oak Club, S. G. Highway, Gota
Ahmadabad
GUJARAT
382481
India |
| Phone |
07940202375 |
| Fax |
07940202021 |
| Email |
prashantmodi@lambda-cro.com |
|
|
Source of Monetary or Material Support
|
| Intas Pharmaceuticals Ltd, Corporate House, Nr. Sola Bridge, S.G. Highway, Thaltej, Ahmedabad – 380054, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Intas Pharmaceuticals Ltd |
| Address |
Corporate House, Nr. Sola Bridge, S.G. Highway, Thaltej, Ahmedabad – 380054, Gujarat, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prabhat Ranjan Sinha |
Aakash Healthcare Super Speciality Hospital |
Department of Clinical Research,Room No.NA,Hospital Plot, Road No 201, Sector 3 Dwarka, New Delhi-110075
New Delhi
DELHI |
9811709628
drprabhatsinha@yahoo.com |
| Dr Anupama Behara |
All India Institute of Medical Sciences |
Dept of General Medicine, Room No.: NA, AIIMS, Sijua, Patrapada, Bhubaneswar
Khordha
ORISSA |
9437800568
anupama6799@gmail.com |
| Dr Dhiren Solanki |
Amena Khatun multi speciality hospital |
Department of Clinical Research, Room No.: NA, Amena Lhatun multi speciality Hospital, Sarkhej Road
Ahmadabad
GUJARAT |
9909917942
dhirensol.1985@gmail.com |
| Dr Arunkumar Radhakrishnan |
Chettinad Hospital & Research Institute |
Department of Clinical Research, Room No.: NA, Rajiv Gandhi Sale, Old Mahabalipunem, Kelambalekem
Chennai
TAMIL NADU |
8589951229
drarunresearch2020@gmail.com |
| Dr Abhay Kumar |
IMS and SUN Hospital |
Department of Clinical Research, Room No.: NA, IMS and sun hospital , K8 Kalinge nagar, Ghatelia, Bhubaneswar
Khordha
ORISSA |
9438534785
drabhay76@gmail.com |
| Dr Rajeev Chawla |
Maharaja Agrasen Hospotal |
Department Of medicine, Room No.: NA, Maharaja Agrasen Hospital, West Panjabi Baug, 110026
New Delhi
DELHI |
9811799666
rajeevaastikchawla@yahoo.com |
| Dr Vipul Chavda |
Rudraksha Multispeciality hospital |
Department of Clinical Research, Room No.: NA, 1st Floor, Rajmandir complex,bareja fly over, Bareja
Ahmadabad
GUJARAT |
9909979236
drvpchavda@gmail.com |
| Dr Alpesh Patel |
Shree Nidhi Heart and Medical Hospital |
Department of Clinical Research, Room No.: NA, Rotary Bhavan Road, Opposite panch mahadev temple, shankar nagar society- 384002
Mahesana
GUJARAT |
9825260157
drapshreenidhi@gmail.com |
| Dr Ravindra Thakkar |
V. S General Hospital |
Department of Clinical Research,Room No. N/A,V. S General Hospital, 2nd Floor Medicine OPD, Ellis bridge, Ahmedabad-380006
Ahmadabad
GUJARAT |
8000496619
ravindrathakkar007@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Akash healthcare Super Speciality Hospital,Dr. Prabhat Ranjan Sinha |
Approved |
| Amena Khatun Hospital Ethics committee, Dr Dhiren Solanki |
Approved |
| IEC IMS and sun Hospitals, Dr. Abhay Kumar |
Submittted/Under Review |
| IHEC Chettinad Academy & Research and Education, Dr. Arunkumar Radhakrishnan |
Approved |
| Institutional Ethics Committee, Dr. Anupama Behara |
Submittted/Under Review |
| Institutional Ethics Committee, Dr. Rajiv Chawala |
Approved |
| Rudraksh Hospital Ethics Committee, Dr. Vipul Chavda |
Approved |
| Shree nidhi Heart and medical Hospital Ethics committee, Dr.Alpesh Patel |
Approved |
| Shrey Hospital Institutional Ethics committee,Dr Ravindra Thakkar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arm 1 (T1): Tablet Metformin SR 1000 mg and Tablet thymoquinone 12.5 mg |
Dose: 1000 mg and 12.5 mg, Route of administration: Oral,Frequency: Once daily, Duration: 90 days |
| Intervention |
Arm 2 (T2): Tablet Metformin SR 1000 mg and Tablet thymoquinone 25 mg |
Dose: 1000 mg and 25 mg, Route of administration: Oral,Frequency: Once daily, Duration: 90 days |
| Comparator Agent |
Arm 3 (R): Metformin SR 1000 mg tablet |
Dose: 1000 mg, Route of administration: Oral,Frequency: Once daily, Duration: 90 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either gender between 18 and 65 years (both inclusive) of age.
2. Patients with type 2 diabetes mellitus.
3. Body mass index (BMI) between 18 kg/m2 to 30 kg/m2 (both inclusive)
4. Patients who are receiving stable dose of metformin 1000 mg/day for last 3 months
5. Patients with HbA1c greater than or equal to 7.0 percentage and less than or equal to 7.5 percentage.
6. Provides written informed consent in accordance with applicable regulatory requirements.
7. Women of child bearing potential must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives (any hormonal method in conjunction with a secondary method), intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile (at least 6 months prior to study drug administration) sexual partner for at least 4 weeks prior to study drug administration, during study and up to 30 days after the last dose of study drug. Male patients must agree to use a male condom throughout the study.
8. Serum pregnancy test at screening and urine pregnancy test at check-in must be negative for women of child bearing potential (WOCBP).
|
|
| ExclusionCriteria |
| Details |
1. Patients taking other oral/injectable antidiabetic agents (e.g. sulfonylurea, insulin) within last 3 months before screening.
2. Patients on drugs (e.g. steroids, hydroxychloroquine etc.) or herbal products or food (including black cumin seeds) affecting blood glucose within last 3 months prior to screening (exception of ongoing statin therapy / beta blockers in recommended doses that is stable for last 3 months).
3. Patients with drug abuse including narcotics, opioids or any other addictive substances.
4. Any major organ system disease, chronic cardiac illness (e.g. ischaemic heart disease, heart failure, cardiac arrythmias), chronic liver disease (e.g. hepatic failure, active hepatitis, liver cirrhosis), renal complications and any other chronic debilitating illness.
5. Women of childbearing potential not agreeing to use an effective form of contraception.
6. Known hypersensitivity to Thymoquinone or metformin or any of its ingredients.
7. Creatinine clearance less than or equal to 60 ml/min or known case of renal impairment.
8. Clinically significant laboratory abnormalities at the time of screening.
9. Patients participated in any type of clinical study within the last 30 days of the screening date.
10. Any other condition which in the opinion of the investigator could jeopardize the safety of the subject or the validity of the study results. Unsuitability for enrollment otherwise as decided by investigator.
11. Patients for whom oral administration of drug is not possible.
12. Treatment with anti-obesity drugs within last 3 months prior to screening or patients who have undergone bariatric surgery.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percent change in HbA1c from baseline to EOS |
On Day 1, Day 30, Day 60 and Day 91 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Proportions of patients achieving HbA1c 7 % at EOS
2. Change in fasting blood glucose (FBG) from baseline to EOS
3. Change in post prandial blood glucose (PPBG) from baseline to EOS
4. Change in body weight from baseline to EOS
5. Change in the non-HDL cholesterol levels (total cholesterol – HDL levels) from baseline to EOS
Safety Evaluation
-Number of episodes of hypoglycemia in each arm from baseline to EOS
- Incidence of adverse events and serious adverse events in each arm |
1. On Day 1, 30, 60 and 91
2. & 3. On Day 1, 15, 30, 60 and 91
4. On Day 1, 7, 15, 30, 60 and 91
5. On Day 1, 30, 60 and 91 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/09/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients of either gender between 18 and 65 years of age (both inclusive) with primary diagnosis of type 2 diabetes mellitus who are on a stable dose of metformin 1000 mg/ day for last 3 months before screening will be considered eligible for the screening. Patients will be randomized in 1:1:1 manner in either Arm 1 or Arm 2 or Arm 3. Patients in Arm 1 will receive 1 tablet of metformin SR 1000 mg once daily and 1 tablet of Thymoquinone 12.5 mg once daily for 90 days. Patients in Arm 2 will receive 1 tablet of metformin SR 1000 mg once daily and 1 tablet of Thymoquinone 25 mg once daily for 90 days. Patients in arm 3 will receive 1 tablet of metformin-SR 1000 mg once daily for 90 days. EOS will be performed on day 91. IP will be administered after dinner. |