| CTRI Number |
CTRI/2023/04/051578 [Registered on: 13/04/2023] Trial Registered Prospectively |
| Last Modified On: |
12/04/2023 |
| 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
|
A clinical study by using Kushthadi churna with Mustadi kwath in Prameha with special reference to hyperglycemia in Type 2 Diabetes melitus |
|
Scientific Title of Study
|
Open randomised controlled clinical study of efficacy of Kushthadi Churna(Harit samhita)with Mustadi kwath(Bhaishajya Ratnavali)in the clinical management of Prameha with special reference to hyperglycemia in Type 2 Diabetes melitus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrPooja Satyanand Prabhu |
| Designation |
PG Scholar |
| Affiliation |
APMs Ayurved Mahavidyalay Sion |
| Address |
Kayachikitsa Department 4th floor,APMs Ayurved Mahavidyalay Sion
Mumbai
MAHARASHTRA
400022
India |
| Phone |
8692051424 |
| Fax |
|
| Email |
prabhupooja61996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAnaya Ashish Pathrikar |
| Designation |
HOD and guide |
| Affiliation |
APMs Ayurved Mahavidyalay Sion |
| Address |
Kayachikitsa Department 4th floor,APMs Ayurved Mahavidyalay Sion
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9870214595 |
| Fax |
|
| Email |
anayapathrikar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAnaya Ashish Pathrikar |
| Designation |
HOD and guide |
| Affiliation |
APMs Ayurved Mahavidyalay Sion |
| Address |
Kayachikitsa Department 4th floor,APMs Ayurved Mahavidyalay Sion
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9870214595 |
| Fax |
|
| Email |
anayapathrikar@gmail.com |
|
|
Source of Monetary or Material Support
|
| APMs Ayurved Mahavidyalay Sion |
|
|
Primary Sponsor
|
| Name |
Sheth RV Ayurvedic hospital and Sheth VM charitable dispensary |
| Address |
Kayachikitsa Department 4th floor,APMs Ayurved Mahavidyalay Sion |
| 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 |
| DrPooja Satyanand Prabhu |
APMs Ayurved Mahavidyalay Sion |
kayachikitsa department,4th floor,OPD no.9 & 10
Ayurved Mahavidyalay Sion, besides sion railway station, mumbai
Mumbai
MAHARASHTRA |
8692051424
prabhupooja61996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ayurvidya Prasarak Mandal IEC |
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. Ayurveda Condition: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Mustadi kwath, Reference: bhaishajya ratnavali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -madhu), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: kushthadi churna, Reference: harit samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
BSL fasting ->110mg/dl to 180 mg/dl
post prandial->140mg/dl to 280 mg/dl |
|
| ExclusionCriteria |
| Details |
patients on insulin therapy
patients with nephropathy,h/o diabetic keto acidosis,immunosuppressant drugs.
pregnant women and lactating mother |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To check for the symptomatic relief as per the gradation mentioned in subjective and objective criteria |
15th day 30th day 45th day 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To check for the adverse drug effect of kushthadi churna |
15th day ,30th day ,45th day ,60th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
22/04/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The prevalence rate of Diabetes has increased from 7.1% in 2009 to 8.4%in 2019. Ayurveda elaborated about Prameha in details classifying into 2 types -santarpanottha & apatarpanottha. Diabetes can be treated and its complications can be avoided or delayed with proper diet, physical activity, medication,regular screening and treatment. So work in ayurveda to search additional safe and effective treatment in Prameha(diabetes) is needed, along with Nidanparivarjan |