| CTRI Number |
CTRI/2024/03/063484 [Registered on: 04/03/2024] Trial Registered Prospectively |
| Last Modified On: |
02/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study regarding effect of ayurvedic churn in diabetes |
|
Scientific Title of Study
|
Randomised controlled clinical study to evaluate the efficacy of Vidangadi churn in prameha purvarupavastha with special reference to prediabetic subject |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VD Dnyanesh Sambhaji Deshmuukh |
| Designation |
PG SCHOLAR |
| Affiliation |
Ayurved Seva Sangh Ayurved Mahavidyalaya Ganeshwadi, Panchavati Nashik |
| Address |
Department of Kayachikittsa Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
7385925496 |
| Fax |
|
| Email |
dnyandeshmukh777@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Harish Garge |
| Designation |
associate professor |
| Affiliation |
Ayurved Seva Sanghas Ayurved Mahavidyalaya Nashik |
| Address |
Department of Kayachikittsa Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9405366160 |
| Fax |
|
| Email |
drhgarge@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Harish Garge |
| Designation |
Assocoate Professor |
| Affiliation |
Ayurved Seva Sangh Ayurved Mahavidyalaya |
| Address |
Department of Kayachikittsa Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9405366160 |
| Fax |
|
| Email |
drhgarge@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurved Seva Sangh Ayurved Mahavidyalaya panchavati Nashik |
|
|
Primary Sponsor
|
| Name |
VD Dnyanesh Sambhaji Deshmukh |
| Address |
Ayurved Seva Sangh Ayurved Mahavidyalaya Panchavati Nashik 422003 |
| 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 |
| VD Dnyanesh Deshmukh |
Ayurved Seva Sanghas Ayurved Mahavidyalaya Nashik |
OPD NO 14 Kayachikitsa OPD
Nashik
MAHARASHTRA |
7385925496
dnyandeshmukh777@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe Ayurved Mahavidyalaya Nashik |
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: PRAMEHA-PURVARUPAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: vidangadi churn, Reference: yogratnakar, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -honey), Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: parijatak ghanvati, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients showing sign and symptoms of prediabetic and Hba1c value between 5.7 to 6.4 |
|
| ExclusionCriteria |
| Details |
IDDM patients
Juvenile Diabetes Acromegaly Cushing’s syndrome pancreatic disorders
Pregnancy Unconscious patients
Severe gastrointestinal diseases Liver diseases tumors conditions like
cardiovasculardisease acute myocardial infarction immune-compromised disease(HIV) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in HbA1c level |
3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in fatigue, naktamutrata |
3 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
11/03/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Ayurvedic approach in the management of Prediabetes by using vidangadi churn. improvement in Hba1c in 3 month by using vidangadi churn orally in prediabetes. sample size are 70. Two group are selected group A and group B. In group A application of vidangadi churn 5gm Bd and in controlled group application of parijatak ghanvati. observe the result that by using vidangadi churn improvement in Hba1c or not |