| CTRI Number |
CTRI/2022/07/044151 [Registered on: 19/07/2022] Trial Registered Prospectively |
| Last Modified On: |
19/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
observational |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of Medovaha srotas dushti in Diabetes Melitus |
|
Scientific Title of Study
|
Assessment of Medovaha srotas dushti in madhumeha(diabetes melitus) in context of HbA1c |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ruby Rani Agarwal |
| Designation |
Professor and H.O.D. |
| Affiliation |
Rishikul Campus, Uttarakhand Ayurvedic University, Haridwar |
| Address |
Opd No. 21 & IPD, Department of Rog Nidan, Rishikul Campus, Uttarakhand Ayurvedic University, Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9456100745 |
| Fax |
|
| Email |
ruby6758@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruby Rani Agarwal |
| Designation |
Professor and H.O.D. |
| Affiliation |
Rishikul Campus, Uttarakhand Ayurvedic University, Haridwar |
| Address |
Opd No. 21 & IPD, Department of Rog Nidan, Rishikul Campus, Uttarakhand Ayurvedic University, Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9456100745 |
| Fax |
|
| Email |
ruby6758@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Saurabh Garg |
| Designation |
PG Scholar |
| Affiliation |
Rishikul Campus, Uttarakhand Ayurvedic University, Haridwar |
| Address |
Opd No. 21 & IPD, Department of Rog Nidan, Rishikul Campus, Uttarakhand Ayurvedic University, Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9034687236 |
| Fax |
|
| Email |
gargsaurabh133@gmail.com |
|
|
Source of Monetary or Material Support
|
| Opd No. 21 & IPD, Department of Rog Nidan, Rishikul Campus, Uttarakhand Ayurvedic University, Haridwar |
|
|
Primary Sponsor
|
| Name |
Uttarakhand Ayurvedic University |
| Address |
Uttarakhand Ayurvedic University, Harrawala, Dehradun |
| 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 Saurabh Garg |
Rishikul Campus, UAU, Haridwar |
Opd No. 21, Department of Rog Nidan, Rishikul Campus, Uttarakhand Ayurvedic University, Haridwar
Hardwar
UTTARANCHAL |
9034687236
gargsaurabh133@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E109||Type 1 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of increase level of Fasting blood sugar, positive urine sugar, HbA1c etc. |
|
| ExclusionCriteria |
| Details |
1. Age of patient less than 16 years and more than 70 years.
2. Patients with juvenile diabetes.
3. Emergency cases in diabetes mellitus.
4. Pregnancy (Gestational diabetes mellitus).
5. Patients having IDDM and receiving insulin (type 1)
6. Chronic complications (micro vascular and Macro vascular) are discarded.
7. Patients with drug induced obesity and neuroendocrine disorder.
8. Genetic syndrome.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Study of Medovaha Stṛotoduśti in diabetes mellitus patients with raised HbA1c and raised Fasting
Blood Sugar. |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Study of Medovaha Stṛotoduśti in diabetes mellitus patients with objective and subjective criteria. |
01 month |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/07/2022 |
| 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="6"
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
|
Madhumeha is considered as a condition of the body that results from vitiated
meda dhatu. Vitiated meda dhatu is related with diabetes melitus. In present era, there
are various diagnostic tools such as Fasting Blood Sugar, Post Parandial Blood Sugar and HbA1c are present for the assessment of obesity. This is an era for Ayurveda to go
hand in hand with modern science to cope up with Various diagnostic difficulties
and also to prove diagnostic methods described in Ayurveda as per modern
science with evidence. |