| CTRI Number |
CTRI/2025/03/082562 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
26/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Diet] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A STUDY TO COMPARE THE EFFECT OF VIDANGA CHOORNA AND TAKRA WITH SELECTED DIETARY MODIFICATIONS IN MANAGING PREDIABETES |
|
Scientific Title of Study
|
A COMPARATIVE TRIAL TO EVALUATE THE EFFECT OF VIDANGA CHOORNA AND TAKRA WITH SELECTED DIETARY MODIFICATIONS IN PREDIABETES |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
GEETHU PRAKASH M |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVERNMENT AYURVEDA COLLEGE THIRUVANANTHAPURAM |
| Address |
GOVERNMENT AYURVEDA COLLEGE THIRUVANANTHAPURAM
DEPARTMENT OF SWASTHAVRITTA
OP NO 2
GOVERNMENT AYURVEDA COLLEGE PANCHAKARMA HOSPITAL POOJAPPURA
Thiruvananthapuram
KERALA
695012
India |
| Phone |
9061423730 |
| Fax |
|
| Email |
geethuprakash13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
GEETHU PRAKASH M |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVERNMENT AYURVEDA COLLEGE THIRUVANANTHAPURAM |
| Address |
GOVERNMENT AYURVEDA COLLEGE THIRUVANANTHAPURAM
DEPARTMENT OF SWASTHAVRITTA
OP NO 2
GOVERNMENT AYURVEDA COLLEGE PANCHAKARMA HOSPITAL POOJAPPURA
KERALA
695012
India |
| Phone |
9061423730 |
| Fax |
|
| Email |
geethuprakash13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SAJITHA BHADRAN |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
GOVERNMENT AYURVEDA COLLEGE THIRUVANANTHAPURAM |
| Address |
GOVERNMENT AYURVEDA COLLEGE THIRUVANANTHAPURAM
DEPARTMENT OF SWASTHAVRITTA
OP NO 2
GOVERNMENT AYURVEDA COLLEGE PANCHAKARMA HOSPITAL POOJAPPURA
Thiruvananthapuram
KERALA
695012
India |
| Phone |
9447452491 |
| Fax |
|
| Email |
sajithabhadran@yahoo.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT AYURVEDA COLLEGE THIRUVANANTHAPURAM |
|
|
Primary Sponsor
|
| Name |
GEETHU PRAKASH M |
| Address |
PG SCHOLAR GOVERNMENT AYURVEDA COLLEGE THIRUVANANTHAPURAM
DEPARTMENT OF SWASTHAVRITTA
OP NO 2 GOVERNMENT AYURVEDA COLLEGE PANCHAKARMA HOSPITAL POOJAPPURA |
| Type of Sponsor |
Other [SELF ] |
|
|
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 GEETHU PRAKASH M |
GOVERNMENT AYURVEDA COLLEGE PANCHAKARMA HOSPITAL POOJAPPURA |
GOVERNMENT AYURVEDA COLLEGE
THIRUVANANTHAPURAM
DEPARTMENT OF SWASTHAVRITTA
OP NO 2
GOVERNMENT AYURVEDA PANCHAKARMA HOSPITAL POOJAPPURA
Thiruvananthapuram
KERALA |
9061423730
geethuprakash13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GOVERNMENT AYURVEDA COLLEGE THIRUVANANTHAPURAM KERALA INDIA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E888||Other specified metabolic disorders. Ayurveda Condition: PRAMEHA-PURVARUPAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vidanga choorna, Reference: Vaidhya Manorama , Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Takra), Additional Information: -Dietary modifications | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:Dietary modifications , Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Participants irrespective of gender
2)Participants in the age group of 35-60 yrs
3)Having FBS value between 100-125mg/dl
Either any of these;
4)PPBS Value between 140-199mg/dl
5)Having HbA1C value between 5.7-6.4%
|
|
| ExclusionCriteria |
| Details |
1)Diagnosed case of PCOS under medications
2)Pregnant ladies and lactating women
3)Malignancy
4)Diagnosed cases of other endocrine disorders and thyroid problems
5)Any chronic systemic disorders
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in FBS, PPBS, HbA1C |
FBS -0th,31st,61st and 91st day
PPBS-0th,31st,61st and 91st
day
HbA1C - 0th and 91st day |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
10/04/2025 |
| 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="1"
Months="6"
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
|
Prediabetes is a salient state of Hyperglycaemia or Hyperinsulinaemia that often precedes a diagnosis of Type 2 diabetes (T2DM ). It is projected that by 2040, almost 8% of the global population will have prediabetes, with approximately 70% progressing to T2DM within their lifetime.1 Although at present prediabetes is considered as mild disease, the shift towards acceptance as an independent pathological entity is supported by inclusion in the 2015 International Statistical Classification of Diseases and Related Health Problems (ICD).This inclusion is important for public perception as it conveys the medically supported need for treatment or intervention. According to Ayurveda Vidanga choorna with Takra is explained in the Vaidhya Manorama in Prameha chiktsa. The objective of the study is to find out the effect of Vidanga choorna with Takra in Prediabetic population in achieving glycemic control. 66 participants irrespective of gender in the age group of 35-60 years with FBS value 100-125mg/dl, PPBS value 140-199 mg/dl and HbA1C value 5.7-6.4% are selected for this Quasi Experimental study from the OPD of Swasthavritta, Govt.Ayurveda college, Thiruvananthapuram and are consecutively allocated into 2 groups, namely study group and control group. The participants in the study group will be instructed to take 6gm of Vidanga choorna along with 100 ml of Takra in two divided dose along with Dietary Modifications while the control group will be instructed to follow Dietary Modifications only . The study period is 90days.The outcome measurements will be analysed through blood investigations of FBS, PPBS, 0th day, 31st ,61st and 91st day and HbA1c on 0th day and 91st day.
|