| CTRI Number |
CTRI/2022/03/041081 [Registered on: 14/03/2022] Trial Registered Prospectively |
| Last Modified On: |
11/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Management] |
| Study Design |
Other |
|
Public Title of Study
|
To Maintain Sugar Level by Ayurveda Medicines and Lifestyle Modification |
|
Scientific Title of Study
|
A Comparative Clinical Study Of Pathadikwath Ghanvati With Meshsringi Kwath Anupan And Life Style Modification In The Management Of Madhumeha Vyadhi W.S.R. To Type-II DM |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jayalata sahu |
| Designation |
Pg Scholar In Department Of Kayachikitsa |
| Affiliation |
Shri Narayan Prasad Awasthi Govt Ayurveda Collage Raipur Chattisgarh 492001 India |
| Address |
Department of Kayachiktsa Shri Narayan Prasad Awasthi Govt Ayurveda Collage Raipur Chhattisgarh 492010 India
Department of Kayachikitsa Shri Narayan Prasad Awasthi Govt Ayurveda Collage Raipur Chhattisgarh 492010 India
Raipur
CHHATTISGARH
492010
India |
| Phone |
8770061275 |
| Fax |
|
| Email |
sahujaya2694@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pramod Kumar Baghel |
| Designation |
Lecturer in Department of Kayachikitsa |
| Affiliation |
Shri Narayan Prasad Awasthi Govt Ayurveda Collage Raipur Chhattisgarh 492010 India |
| Address |
Department of Kaya Chikitsa Shri Narayan Prasad Awasthi Govt Ayurveda Collage Raipur Chhattisgarh 492010 India
Department of Kaya Chikitsa Shri Narayan Prasad Awasthi Govt Ayurveda Collage Raipur Chhattisgarh 492010 India
Raipur
CHHATTISGARH
492010
India |
| Phone |
8959762200 |
| Fax |
|
| Email |
drpkbaghel08@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pramod Kumar Baghel |
| Designation |
Lecturer in Department of Kayachikitsa |
| Affiliation |
Shri Narayan Prasad Awasthi Govt Ayurveda Collage Raipur Chhattisgarh 492010 India |
| Address |
Shri Narayan Prasad Awasthi Govt Ayurveda Collage Raipur Chhattisgarh 492010 India
Shri Narayan Prasad Awasthi Govt Ayurveda Collage Raipur Chhattisgarh 492010 India
CHHATTISGARH
492010
India |
| Phone |
8959762200 |
| Fax |
|
| Email |
drpkbaghel08@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kayachikitsa shri Narayan Prasad Awasthi Govt Ayurveda collage Raipur chhattisgarh 492010 |
|
|
Primary Sponsor
|
| Name |
Department of Kayachikitsa shri Narayan Prasad Awasthi Govt Ayurveda collage Raipur |
| Address |
Shri Narayan Prasad Awasthi Govt Ayurveda Collage Raipur Chhattisgarh 492010 India |
| 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 Jayalata sahu |
kayachikitasa opd no 2 and 18 Shri khudadad doonga ji govt. ayurveda hospital Raipur Chattisgarh |
Department Of Kaya Chikitsa Shri Narayan Prasad Awasthi Govt Ayurveda Collage and Rospital Raipur Chattisgarh
Raipur
CHHATTISGARH |
8770061275
sahujaya2694@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee |
Approved |
| Institutional Ethical 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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Pathadikwath ghanvati and meshsringi kwath anupan, Reference: chakradutta prameha chikitsa 35/15 and , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -meshsringi kwath anupan), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age Between 21 Year to 60 Year
sex both Male and Female
Patient Having Symptoms of Type II DM
Fasting blood sugar >126 Mg /dl and <200mg /dl
post prandial blood sugar >200 mg/dl and <350 mg /dl
hba1c level >6.4 and <9% |
|
| ExclusionCriteria |
| Details |
age <21 and >60
Type I dm
fasting blood sugar <126 and >200 mg /dl
post prandial blood sugar <200 nad > 350 mg /dl
Hba1c <6.4 and >9%
pregnant and lactating women
complicated DM |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To maintain Blood Glucose Level By Pure Ayurveda Medicines without Modern Medicine |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Maintain Blood Glucose Level By Ayurveda Medicine and Lifestyle Modification And Improve Qwality Of life |
60 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
25/03/2022 |
| 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="0"
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
|
Diabetes mallitus is a metabolic disease which affect the most of the population now a day and our ayurveda medicin is able to maintain normal blood glucose level |