| CTRI Number |
CTRI/2022/09/045137 [Registered on: 01/09/2022] Trial Registered Prospectively |
| Last Modified On: |
25/08/2022 |
| 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
|
aetiopathological and clinical study of Madhumeha with special reference to Type 2 Diabetes Mellitus |
|
Scientific Title of Study
|
Nidanatmak(aetiopathological) and upashayatmak(clinical )study of Madhumeha with special reference to Type 2 Diabetes Mellitus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rekha |
| Designation |
Specialist Ayurveda, |
| Affiliation |
DY Patil University School of Ayurveda |
| Address |
AYUSH Hospital, Junglighat , Portblair, Andaman and Nicobar island, pin 744103
DY Patil University School of Ayurveda, Sector 7,Nerul, Navi Mumbai
Andamans
ANDAMAN & NICOBAR ISLANDS
744103
India |
| Phone |
9932080905 |
| Fax |
|
| Email |
drsinghrekha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Santhosh Chavhan |
| Designation |
Professor, Rognidan |
| Affiliation |
Dypatil University School of Ayurveda |
| Address |
DyPatil University, School of Ayurveda, Sector -7, Nerul, Navi Mumbai , Maharastra
DyPatil University, School of Ayurveda, Sector-7, Nerul, Navi Mumbai , Maharastra
Mumbai
MAHARASHTRA
400706
India |
| Phone |
9167778502 |
| Fax |
|
| Email |
Santosh.chavhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rekha |
| Designation |
Phd Scholar |
| Affiliation |
Dy Patil University, School of Ayurveda |
| Address |
DYPatil University, School of Ayurveda, Sector-7,Nerul, Navi Mumbai, Maharastra
DYPatil University, School of Ayurveda, Sector-7,Nerul, Navi Mumbai, Maharastra
Mumbai
MAHARASHTRA
400706
India |
| Phone |
9932080905 |
| Fax |
|
| Email |
drsinghrekha@gmail.com |
|
|
Source of Monetary or Material Support
|
| DY PATIL UNIVERSITY, SCHOOL OF AYURVEDA,NERUL,NAVI MUMBAI, MAHARASTRA |
|
|
Primary Sponsor
|
| Name |
School of Ayurveda Hospital DY Patil University |
| Address |
Dy patil university, School of Ayurveda,Nerul ,navi mumbai |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rekha |
DY Patil university, School of Ayurveda hospital, |
Dy patil university, school of Ayurveda, hospital, Rog nidan vikruti vigyan department , room no 1, Nerul, Navi Mumbai
Mumbai
MAHARASHTRA |
9932080905
drsinghrekha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethic Committee of School of Ayurveda |
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, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Guduchi, Reference: Sharangadhar Samhita, swaras kalpana, Route: Oral, Dosage Form: Swaras/ Juice, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: -nil | | 2 | Comparator Arm (Non Ayurveda) | | - | met formin | metformin -500mg xbd |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Inclusion Criteria –
Patients between age group 30 to 60 years.
Newly Diagnosed cases of Diabetes mellitus less than 6months
FBS- 130-160 mg/dl and PP- 150- 220mg/dl
HbA1c
|
|
| ExclusionCriteria |
| Details |
1. Patients of age less than 20 years and above 60 years.
2. Pregnant woman
3. Patients with serious disorders like MI, CHF, cirrhosis of liver, severe complicated DM.
4. Patients taking drugs like corticosteroids, antidepressant
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Sample Size-100 patients
Group-2
Group A -50 patients and GroupB-50 patients
Test- Paired T Test
Wilcoxon matched pairs
Signed rank test
|
Time Points
Completion of trail- 2 Years
Duration of trail-90 days
Follow up-15 days
30 days
45 days
60 days
75 days
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
05/09/2022 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomised double blind contro parallel group aims to study aetiopathology of madhumeha and Upashayatmak effect of guduchi swaras on glucose level of diabetes patients . One group 50 patients given giloy swaras 15 ml x bd with honey and another group 50 patients control group given metformin -500mg xbd with water . |