| CTRI Number |
CTRI/2022/08/044566 [Registered on: 02/08/2022] Trial Registered Prospectively |
| Last Modified On: |
30/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of haridradi yog in covid-19 recovered patients of diabetes mellitus type 2 |
|
Scientific Title of Study
|
An etiopathological study and therapeutic intervention of haridradi yog(A hypothetical ayurvedic formulation) on covid-19 recovered patients of madhumeha w.s.r 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 Sunita kumari |
| Designation |
PG Scholar |
| Affiliation |
Madan Mohan Malviya Government Ayurved College |
| Address |
PG Department of Rog Nidan Evum Vikriti Vigyan Madan Mohan Malviya Government Ayurved College ,udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
7073933686 |
| Fax |
|
| Email |
sunitaindoria19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Man Mohan Sharma |
| Designation |
Associate Professor |
| Affiliation |
Madan Mohan Malviya Government Ayurved College |
| Address |
PG Department of Rog Nidan Evum Vikriti Vigyan Madan Mohan Malviya Government Ayurved College ,udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9887364809 |
| Fax |
|
| Email |
drmmsharma72@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Man Mohan Sharma |
| Designation |
Associate Professor |
| Affiliation |
Madan Mohan Malviya Government Ayurved College |
| Address |
PG Department of Rog Nidan Evum Vikriti Vigyan Madan Mohan Malviya Government Ayurved College ,udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
|
| Fax |
|
| Email |
drmmsharma72@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madan Mohan Malviya Government Ayurved College ,udaipur |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malviya Government Ayurved College udaipur |
| Address |
Madan Mohan Malviya Government Ayurved College ,ambamata scheme udaipur |
| Type of Sponsor |
Government medical college |
|
|
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 Sunita Kumari |
Madan Mohan Malviya Government Ayurved College |
OPD no. 2 PG Department of Rog Nidan Evum vikriti Vigyan Associated Hospitals of Madan Mohan Malviya Government Ayurved College ,udaipur RAJASTHAN
Udaipur
RAJASTHAN |
7073933686
sunitaindoria19@gmail.com |
|
|
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:E118||Type 2 diabetes mellitus with unspecified complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Haridradi yog, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: lukewarm water), Additional Information: nil |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Diabetic Patients who recovered from the Covid-19 infection.
2.The patiens having clinical sign & symptoms of Madhumeha/Diabetes Mallitus |
|
| ExclusionCriteria |
| Details |
1. Patients having IDDM (type -1 )
2. Cronic Complications (microvascular & macrovascular0
3. patients who have not been infected with Covid 19 infection |
|
|
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 |
1. Improvement in sign & symptoms of madhumeha
2.improvement in Blood sugar |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Improvement in sign & symptoms of madhumeha
2.improvement in Blood sugar |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
30/09/2022 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 is a clinical study to evaluate the therapeutic effect of haridradi yog in madhumeha .it is single arm study in which 30 patients will be administered with 5 grm of Haridradi yog BD |