| CTRI Number |
CTRI/2025/01/079099 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
19/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Preventive
Behavioral
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic Diet and Lifestyle Intervention For Management of Pre-Diabetes. |
|
Scientific Title of Study
|
Ayurveda Based Diet and Behavioral
Lifestyle Intervention For Management of Pre-Diabetes-A Community Based Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Delvin T Robin |
| Designation |
Professor |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Room Number 36, 3rd floor
Department of Swasthavritta
Amrita School of Ayurveda,
Amritapuri Campus,
Clappana P.O.
Kollam
Kollam
KERALA
690525
India |
| Phone |
7907780083 |
| Fax |
|
| Email |
delvintr@ay.amrita.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Delvin T Robin |
| Designation |
Professor |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Room Number 36, 3rd floor
Department of Swasthavritta
Amrita School of Ayurveda,
Amritapuri Campus,
Clappana P.O.
Kollam
Kollam
KERALA
690525
India |
| Phone |
7907780083 |
| Fax |
|
| Email |
delvintr@ay.amrita.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Delvin T Robin |
| Designation |
Professor |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Room Number 36, 3rd floor
Department of Swasthavritta
Amrita School of Ayurveda,
Amritapuri Campus,
Clappana P.O.
Kollam
Kollam
KERALA
690525
India |
| Phone |
7907780083 |
| Fax |
|
| Email |
delvintr@ay.amrita.edu |
|
|
Source of Monetary or Material Support
|
| Ayurswasthya Yojana Scheme-Ministry of Ayush
Government of India
Ayush Bhavan, B Block,
G.P.O Complex, INA
New Delhi-23 |
|
|
Primary Sponsor
|
| Name |
Ayurswasthya Yojana Scheme |
| Address |
Ministry of Ayush,
Government of India,
Ayush Bhavan, B Block,
G.P.O Complex, INA,
New Delhi-23 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Amrita School of Ayurveda |
Amrita School of Ayurveda,
Amritapuri Campus,
Clappana P.O.
Kollam
Pin.690525 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Delvin T Robin |
Amrita School of Ayurveda |
3rd Floor, Room number 410
Department of Swasthavritta
Amrita School of Ayurveda,
Amritapuri Campus,
Clappana P.O.
Kollam
Pin.690525
Kollam
KERALA |
7907780083
delvintr@ay.amrita.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amrita School of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R730||Abnormal glucose. Ayurveda Condition: PRAMEHA-PURVARUPAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Asana, Reference: Bhavaprakash, Route: Oral, Dosage Form: Phanta, Dose: 300(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 1 Years, anupAna/sahapAna: No, Additional Information: 8gm choorna boiled in 640 ml of water reduced to 300 ml(2) Medicine Name: Triphala, Reference: AFI, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Years, anupAna/sahapAna: No, Additional Information: 1 tab = 250 mg
2-0-2 After food(3) Medicine Name: Yava , Reference: Charaka Samhita, Route: Topical, Dosage Form: Churna/ Powder, Dose: 100(g), Frequency: sos, Bhaishajya Kal: Abhakta, Duration: 1 Years, anupAna/sahapAna: No, Additional Information: 100 gm of yava choorna for powder massage. once a week for 1 year. |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Either Sex, Age - 35-60, at moderate or high risk for diabetes by Indian Diabetic Risk Score, Pre-diabetic range-5.7%â€6.4% by HbA1c, BMI indicating overweight or obese status. |
|
| ExclusionCriteria |
| Details |
H/o Uncontrolled Hypertension, renal disease, severe heart disease, heart failure, cancer or any serious illness compromising the ability of subject to participate/comply with or complete the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Ayurvedic Diet Therapy (ADT) and Ayurveda Behavioral Lifestyle Intervention (ABLI) in reducing HbA1c levels among individuals with prediabetes. |
Every 4 months HbA1c will be assessed |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the impact of ADT and ABLI on BMI, waist measurement, and weight loss among individuals with prediabetes. |
every 4 months weight, BMI will be assessed. |
| To assess compliance with diet and lifestyle modifications among participants. |
every 4 months |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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 |
|
Date of First Enrollment (India)
|
01/02/2025 |
| 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="3"
Months="0"
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
|
Title Ayurveda Based Diet and Behavioral Lifestyle Intervention for Management of Prediabetes A community based study. Study Focus A community based study evaluating Ayurvedic dietary and lifestyle interventions for managing prediabetes in the Oachira block, Kollam district, Kerala. Background
India, with a high prevalence of diabetes, faces an urgent need for preventive measures. Kerala, with a 19 percent diabetes prevalence, exhibits a higher rate of prediabetes than diabetes. Ayurveda offers a promising approach to reversing prediabetes with its focus on Kapha dominance, which aligns with early diabetic symptoms. Primary Objective
To assess the efficacy of Ayurvedic Diet Therapy (ADT) and Ayurveda Behavioral Lifestyle Intervention (ABLI) in reducing HbA1C levels in individuals with prediabetes. Secondary Objectives: Impact on BMI, waist circumference, and weight loss. Compliance with Ayurvedic interventions. Methodology Population 1000 prediabetic individuals aged 35-60 identified via the Indian Diabetes Risk Score (IDRS) and HbA1C testing. Interventions ADT (herbal drink-Asana toya, Triphala tablets) and ABLI (Udwartana, yoga, lifestyle counseling). Design Pre and post study with follow ups every four months for one year. Outcome Measures Changes in HbA1C, BMI, and waist circumference. |