| CTRI Number |
CTRI/2022/09/045774 [Registered on: 22/09/2022] Trial Registered Prospectively |
| Last Modified On: |
20/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Difference between ikshwaku and jimutaka in the treatment of Asthma |
|
Scientific Title of Study
|
Comparative Study of efficacy of Vamana with Jimutaka Yoga Luffa echinata roxb and
Ikshvaku Churna Yoga Lagenaria siceraria in the management of Tamaka Shwasa
Bronchial Asthma |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Devika Jaydip Topale |
| Designation |
PG SCHOLAR |
| Affiliation |
datta meghe institute of medical sciences |
| Address |
room no 40 department of panchakarma mahatma gandhi ayurved college hospital and research centre
Wardha
MAHARASHTRA
442001
India |
| Phone |
9922951379 |
| Fax |
|
| Email |
djtople1379@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devika Jaydip Topale |
| Designation |
PG SCHOLAR |
| Affiliation |
datta meghe institute of medical sciences |
| Address |
room no 40 department of panchakarma mahatma gandhi ayurved college hospital and research centre
Wardha
MAHARASHTRA
442001
India |
| Phone |
9922951379 |
| Fax |
|
| Email |
djtople1379@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta Parwe |
| Designation |
Professor |
| Affiliation |
datta meghe institute of medical sciences |
| Address |
room no 40 department of panchakarma mahatma gandhi ayurved college hospital and research centre
Wardha
MAHARASHTRA
442001
India |
| Phone |
9403142270 |
| Fax |
|
| Email |
shweta.parwe@dmimsu.edu.in |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College Hospital and Research Centre |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Ayurved College Hospital and Research Centre |
| Address |
room no 40 department of panchakarma mahatma gandhi ayurved college hospital and research centre salod hirapur wardha |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Devika Jaydip Topale |
Mahatma Gandhi Ayurved College Hospital and Research Centre |
room no 40 department of panchakarma mahatma gandhi ayurved college hospital and research centre
Wardha
MAHARASHTRA |
9922951379
djtople1379@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAHATMA GANDHI AYURVED COLLEGE HOSPITAL AND RESEARCH CENTRE INSTITUTIONAL ETHICS COMMITTEE SALOD WARDHA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J452||Mild intermittent asthma. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ikshwaku , Reference: Charaka samhita kalpasthan chapter 3, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: sos, Bhaishajya Kal: Abhakta, Duration: 1 Days, anupAna/sahapAna: Yes(details: Honey), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Jimutaka, Reference: Charaka samhita kalpasthan chapter 2, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: sos, Bhaishajya Kal: Abhakta, Duration: 1 Days, anupAna/sahapAna: Yes(details: Honey), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients between the age group 18 to 50 yrs irrespective of their gender religion
economical status and marital status are included in the study
2 patients having Asthma up to 5 yrs
3 Patients who are fit for Vamana according to ayurvedic classics are included in study
4 Patients only on inhalation therapy are included in the study
5 Patients who are willing to participate in the study |
|
| ExclusionCriteria |
| Details |
1 Patients on steroids
2 Patients having any other pulmonary disorders and Cardiac disorders
3 Patients with Hernia
4 Patient having Asthma chronicity above 5 years |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to assess the efficacy of ikshwaku churna vamak yoga in PFT and CBC with AEC |
11 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to assess the efficacy of jimutaka churna vamak yoga in PFT |
1 week 4 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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/09/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/09/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 volunteers will be informed about the study protocol. willing participants will be randomly selected as per computer generated table. clinical research format will be prepared and validated. prior to the study approval will be taken from IEC, MGACHRC, salod (H) wardha and CTRI registration will be done after selection, each participant will be tested individually and selected according to selection criteria. they are divided into two groups the trial is a parallel group randomized open clinical standard control trial. it will include a 11 days treatment period and at 12th day follow up period. |