| CTRI Number |
CTRI/2025/08/092692 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the efficacy of Ayurvedic Sugar-free drink for the Type 2 Diabetic Patients & prediabetics and Improving Quality of Life. |
|
Scientific Title of Study
|
An Open label, Single arm, clinical Study to evaluate efficacy of Ayurvedic Sugar-free drink for the Type 2 Diabetic Patients & prediabetics and Improving QOL |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| KAMC/IEC/2025-26/GEN-01 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Srinivasa Yathapu Reddy |
| Designation |
Sponsors representative |
| Affiliation |
Dabur India Limited |
| Address |
1st floor Dabur Research and Development Centre Dabur India limited Plot no 22 Site 4 Sahibabad
Ghaziabad
UTTAR PRADESH
201012
India |
| Phone |
|
| Fax |
|
| Email |
srinivasa.yathapu@dabur.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Baidyanath Mishra |
| Designation |
Head Healthcare Research |
| Affiliation |
Dabur India Limited |
| Address |
1st floor Dabur Research and Development Centre Dabur India limited Plot no 22 Site4 Sahibabad
Ghaziabad
UTTAR PRADESH
201012
India |
| Phone |
911203378606 |
| Fax |
|
| Email |
baidyanath.mishra@dabur.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Baidyanath Mishra |
| Designation |
Head Healthcare Research |
| Affiliation |
Dabur India Limited |
| Address |
1st floor Dabur Research and Development Centre Dabur India limited Plot no 22 Site4 Sahibabad
UTTAR PRADESH
201012
India |
| Phone |
911203378606 |
| Fax |
|
| Email |
baidyanath.mishra@dabur.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dabur India Limited |
| Address |
1st floor, Dabur Research and Development Centre, Dabur India limited, Plot no 22,Site 4, Sahibabad Ghaziabad UTTAR PRADESH 201010 India |
| Type of Sponsor |
Other [[Ayurveda Healthcare]] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sushant Kumar Sahu |
Govt Ayurvedic College and hospital |
Department of Kayachikitsa, Tulasi Nagar
Balangir
ORISSA |
94398 63125
drkumarmanoj66@gmail.com |
| Drwaheeda Banu |
Karnataka Ayurveda Medical College |
Dept of PG studies in Kayachikitsa, K.E.C.T Towers Hoigebail, Ashoknagar
Dakshina Kannada
KARNATAKA |
9008137091
drwaheedabanu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Clinical Ethics Committee |
Approved |
| Institutional Ethics Committee of Sushruta Hospital and Trauma Care Private Limited |
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. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: DRDC/2025/010, Reference: NA, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1) Subjects aged more than 18 years of age who agree to participate in the study willing and able to answer the questionnaire and give their written informed consent. 2) For Diabetics-Participant with initial HBA1c value 6.5percent and above. Patients who are under the treatment of oral antidiabetic drugs. Patients who have not changed their medication in the last three months prior to signing up for the study. (However, dosage modifications are allowed). For prediabetics: Participant with initial HBA1c value 5.7 to 6.4 percent.3) Known cases of pre-diabetes with fasting blood sugar not exceeding 130mg/dl with obesity and having family history of diabetes. 3) Subjects with Body Mass Index (BMI) more than 27 kgper m2 and less than 45 kgperm2. 4) Women of childbearing potential must be willing to use double-barrier contraception for the entire study. |
|
| ExclusionCriteria |
| Details |
1) Women with regular menstruation history having missed periods. 2) Confirmed cases of pregnancy and lactation. 3) Patients who are on insulin therapy. 4) Patients with a history of chronic illness type 1 diabetes and /or history of ketoacidosis. 5) Patients with Insulin use and or or hyperosmolar hyperglycaemic state 6) Patients with secondary diabetes (including disease of the exocrine pancreas, endocrinopathies). 7) Any condition of the patient which may have an impact on the objective and outcome of the trial example: patients currently undergoing major/minor surgical procedures. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate changes in the diabetic panel, i.e., random blood sugar, glycosylated haemoglobin (HbA1C), fasting blood sugar. |
At visit 1 (screening & baseline), visit 2 (at week 4), visit 3 (at week 8), visit 4 (at week 12) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate if there is reduction in Body mass index (BMI) and any notable changes in haematology and biochemistry profile leading to improvement in quality of life. |
visit 1, 2, 3 and 4 |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
25/08/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
An Open label, Single arm, clinical Study to
evaluate efficacy of Ayurvedic
Sugar-free drink for the Type 2 Diabetic Patients &
prediabetics and Improving QOL. The objective of current study is to evaluate
the efficacy of Ayurvedic Sugar-free drink for the Type 2 Diabetic Patients
& prediabetics and Improving Quality of Life.Participants as
below will be recruited in 1:2 ratio: Prediabetics
(borderline) and Confirmed diabetics cases concomitantly taking Oral
Hypoglycaemic Drugs. Primary outcome will beTo evaluate changes in the diabetic panel, i.e., random
blood sugar, glycosylated haemoglobin (HbA1C), fasting blood sugar. Secondary outcome will be To evaluate if there is reduction in Body mass index
(BMI) and any notable changes in haematology and biochemistry profile leading
to improvement in quality of life. |