| CTRI Number |
CTRI/2024/03/064207 [Registered on: 15/03/2024] Trial Registered Prospectively |
| Last Modified On: |
09/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Diet supplement] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Anti-diabetic diet supplement |
|
Scientific Title of Study
|
Evaluation of two ready-to-cook dietary supplements for its anti-diabetic property in patients of type-2 diabetes mellitus -A Randomized control trial |
| 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 Sulochana Bhat |
| Designation |
Assistant Director Incharge |
| Affiliation |
Central Ayurveda Research Institute |
| Address |
Room No.16, Hospital wing, Ground floor, 12 Uttarahalli Manavarthe Kaval Kanakapura Main Road Thalaghattapura post
Bangalore
KARNATAKA
560109
India |
| Phone |
9968053646 |
| Fax |
|
| Email |
dr.sulochana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vrinda |
| Designation |
Senior Research fellow |
| Affiliation |
Central Ayurveda Research Institute |
| Address |
Room No.115, First floor, Admin wing, 12 Uttarahalli Manavarthe Kaval Kanakapura Main Road Thalaghattapura post
Bangalore
KARNATAKA
560109
India |
| Phone |
9035996258 |
| Fax |
|
| Email |
vrindabhat_89@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vrinda |
| Designation |
Senior Research fellow |
| Affiliation |
Central Ayurveda Research Institute |
| Address |
Room No.115, First floor, Admin wing, 12 Uttarahalli Manavarthe Kaval Kanakapura Main Road Thalaghattapura post
Bangalore
KARNATAKA
560109
India |
| Phone |
9035996258 |
| Fax |
|
| Email |
vrindabhat_89@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Centre of excellence Scheme, Ayurswasthya Yojana under Minisstry of Ayush, Govt of India |
|
|
Primary Sponsor
|
| Name |
Ayurswasthya Yojana, Ministry of Ayush, Govt of India |
| Address |
Ministry of Ayush, Ayush Bhawan, B Block, GPO Complex, INA, New Delhi – 110023 |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| DrVrinda |
Central Ayurveda Research Institute |
Room No.115, First floor, Admin block, No.12 Uttarahalli Manavarthe Kaval Kanakapura Main Road Thalaghattapura post
Bengaluru-560109
Bangalore
KARNATAKA |
9035996258
vrindabhat_89@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
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 | Comparator Arm (Non Ayurveda) | | - | | Treatment as it is | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Khadiradi Yoga, Reference: Chakradatta- Prameha chikitsa - 35 - 18 / pg 216, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 42 Days, anupAna/sahapAna: Yes(details: Hot water), Additional Information: Pellets of the extracts of drugs are to be dissolved in 100 ml Hot water to prepare a tea and consumed | | 3 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Yavadi supa, Reference: NA, Route: Oral, Dosage Form: Khanda/Granules, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 42 Days, anupAna/sahapAna: Yes(details: 100 ml Hot water), Additional Information: Ready to cook/Instant Soup powder-to be mixed with hot water and consumed |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
I. Subjects of either sex, 18-60 years.
II. Known diabetic subjects with fasting blood glucose between 150mg/dL-200mg/dL(both values included) and/or post prandial blood glucose between 180mg/dL -300mg/dL (both values included)
III. Subjects who are on stable dose of any OHA (Oral hypoglycemic agent).
IV. Subjects who agree to participate in the study and submit a written informed consent form.
|
|
| ExclusionCriteria |
| Details |
I. Subject diagnosed with type 1 Diabetes Mellitus.
II. Subjects who are on Insulin therapy.
III. Patients with confirmed diagnosis of diabetic complications like diabetic retinopathy, neuropathy, nephropathy, non-healing wounds, gangrene/ amputed limbs/toes.
IV. Subjects with Haemoglobin percentage less than 8 g/dl.
V. Subjects with uncontrolled hypertension (with or without medication systolic more than 150 and/or diastolic more than 100 mmHg after 10 minutes of rest)
VI. Subjects with established diagnosis of CAD or any other clinically significant cardiovascular disease.
VII. Subjects with concurrent Hepatic Dysfunction (defined as AST and/or ALT more than 3 times of the upper normal limit)
VIII. Subjects with Renal Dysfunction (defined as eGFR less than 60 ml/min. )
IX. Subjects with Uncontrolled acute Pulmonary Dysfunction requiring inhalation or systemic steroids.
X. Female subject of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study therapy.
XI. Pregnant / Lactating women.
XII. Subjects on systemic or oral steroids, oral contraceptive pills or estrogens replacement therapy.
XIII. Subjects with current diagnosis of malignancy or in last five years.
XIV. Subjects who have completed participation in any other interventional clinical trial during the past three months.
XV. Any other condition which the Investigator thinks may jeopardize the safety of the subject.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Fasting blood glucose (minimum 8 hrs after dinner), Post prandial blood sugar (2 hours after breakfast), Plasma Insulin and HOMA-IR |
Baseline and 42nd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Change in BMI and waist circumference |
Baseline and 42nd day |
| 2. Change in Lipid profile |
Baseline and 42nd day |
| 3. Change in renal function, liver function, hematology, urine analysis |
Baseline and 42nd day |
| 4. Any SAE /ADR or change in laboratory parameters |
Baseline and 42nd day |
| 5. Change in Symptoms – Diabetes Symptom questionnaire (DSQ) |
Baseline and 42nd day |
| 6. Change in Symptoms - Simplified nutritional appetite questionnaire (SNAQ |
Baseline and 42nd day |
| 7. Change in Agni - Agni assessment tool developed by CCRAS |
Baseline and 42nd day |
| 8. Acceptability of the ready-to-cook dietary supplement |
21st day |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/03/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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 diet is a combination of foods, individual or
community habitually eats to exist or live, or use for therapeutic purposes. Conventionally
type-2 diabetes is controlled with diet alone or diet and hypoglycemic agents.
American Diabetes Association has defined self-dietary management as the key
step in providing the diabetics, the knowledge and skill in relation with
treatment, nutritional aspects, medications and complications. Dietary management
of diabetes is not only known to achieve optimal blood glucose but also provide
energy and prevent or delay diabetic complications.(1)
Various studies have reported bio-active phyto-chemicals
in various herbs used as food. The global concern for diversification of these
foods to improve therapeutic use for diabetes control by enhancing the
beneficial constituents in them has risen. There is a need to integrate these
potential foods within innovative systems in accordance with local needs, food habits
and priorities.
Considering the busy life of people these days, two
ready-to-cook formulations were proposed to be developed to evaluate its
efficacy in lowering blood glucose level and also to analyse its effect on Agni (Appetite or digestion) if any. The ingredients used in these formulations will be
FSSAI certified and a standardized product.
|