| CTRI Number |
CTRI/2021/06/034041 [Registered on: 07/06/2021] Trial Registered Prospectively |
| Last Modified On: |
05/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Efficacy of Kushthadi Churna in Madhumeha. |
|
Scientific Title of Study
|
Open Randomized clinical control study on efficacy of Kushthadi Churna in the management
of Madhumeha vis-a-vis to Non Insulin Dependent 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 |
Pratima Prafulla Mohite |
| Designation |
PG Scholar Kayachikitsa |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College and Post Graduate and Research Center Ashta |
| Address |
Hon Shri Annasaheb Dange Ayurved Medical College and Post Graduate and Research Center Ashta Tal-Walwa Dist-Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
8806865823 |
| Fax |
|
| Email |
mohitepratima8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Smita Vitthal Lokhande |
| Designation |
Guide |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College and Post Graduate and Research Center Ashta |
| Address |
Hon Shri Annasaheb Dange Ayurved Medical College and Post Graduate and Research Center Ashta Tal-Walwa Dist-Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
8149556591 |
| Fax |
|
| Email |
yoshitpriya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pratima Prafulla Mohite |
| Designation |
PG Scholar Kayachikitsa |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College and Post Graduate and Research Center Ashta |
| Address |
Hon Shri Annasaheb Dange Ayurved Medical College and Post Graduate and Research Center Ashta Tal-Walwa Dist-Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
8806865823 |
| Fax |
|
| Email |
mohitepratima8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College and Post Graduate and Research Center Ashta Tal Walwa Dist Sangli Maharashtra 416301 |
|
|
Primary Sponsor
|
| Name |
Pratima Prafulla Mohite |
| Address |
Hon Shri Annasaheb Dange Ayurved Medical Collge and Post Graduation and Research Center Ashta Tal-Walwa Dist-Sangli 416301 |
| 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 |
| Pratima Prafulla Mohite |
Hon Shri Annasaheb Dange Ayurveda medical college |
Hon Shri Annasaheb Dange Ayurved Medical Collge and Post Graduation and Research Center,Department of Kayachikitsa,Ashta Tal-Walwa Dist-Sangli 416301
Sangli
MAHARASHTRA |
8806865823
mohitepratima8@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 |
| Healthy Human Volunteers |
Ayurveda health condition Madhumeha(Diabetes Mellitus) |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kushthadi Churna in Madhumeha. |
Kushthadi Churna 1gm BD with Madhu in Madhumeha for 28 days |
| Comparator Agent |
Nishaamalaki Churna in Madhumeha |
Nishaamalaki Churna 1gm BD with Madhu in Madhumeha for 28 Days. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 25-70 years with irrespective of
gender, education, religion, socio-economic class.
2. Patients presenting with classical features of Madhumeha,
that is-
i. Pipasavridhhi (polydipsia)
ii. Prabhut- mutrata(polyuria)
iii. Avila – mutrata (turbidity)
iv. Naktamutrata
3. Patients with history of Madhumeha. |
|
| ExclusionCriteria |
| Details |
Patients with Insulin Dependent Diabetes Mellitus.
2. Patients aged less than 25 years and more than 70 years.
3. Patient presenting with Madhumeha due to the complication
of other major systemic disease.
4. Pregnant women and lactating mothers will be excluded.
5. Any acute emergency conditions. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Determine the efficacy of Kushthadi Churna In Madhumeha. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To review Literature of Madhumeha. |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/06/2021 |
| 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 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
|
I am Pratima Prafulla Mohite PG Scholar Kaya-Chikitsa trying to evaluate the efficacy of Kushthadi Churna in Madhumeha. During this trial trying to evaluate the untoward effect of Kushthadi Churna in Madhumeha as there is no previous work done on Kushthadi Churna. SO emphasis will be made to find out easy,cost effective method to control Hyperglyacemia with no side effects. |