| CTRI Number |
CTRI/2020/06/025967 [Registered on: 18/06/2020] Trial Registered Prospectively |
| Last Modified On: |
12/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
effectiveness of madanaphala vamana in tamakshwasa and comparison with Jeemutaka and Ikshwaku Vamana in Tamakshwasa |
|
Scientific Title of Study
|
Evaluation and comparison of Madanaphala,Jeemutaka and Ikshwaku Vamana in Tamakshwas(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 Kadam Sahebrao Kishanrao |
| Designation |
Associate Professor,HOD, department of Panchakarma |
| Affiliation |
DMM Ayurved college Yavatmal |
| Address |
Mahatma Gandhi ayurved hospital and research center,Department of Panchakarma, Room No. 24,Salod (H), Wardha, Maharashtra
shivaji nagar arni road Yavatmal 445001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9922354892 |
| Fax |
07152-287714 |
| Email |
drsahebraokadam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr shweta parve |
| Designation |
Professor and hod department of panchakarma |
| Affiliation |
Mahatma Gandhi Ayurved College, Hospital and research center Salod(H) wardha maharashtra |
| Address |
Mahatma Gandhi ayurved hospital and research center, Department of Panchakarma, Room No. 24 salod (H) wardha Maharashtra
Mahatma Gandhi ayurved college, hospital and research center salod(H) wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9403142270 |
| Fax |
07152-287714 |
| Email |
drshwetaparve@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr kadam Sahebrao Kishanrao |
| Designation |
Associate Professor and hod department of panhakarma |
| Affiliation |
DMM Ayurved college Yavatmal |
| Address |
Mahatma Gandhi ayurved hospital and research center salod wardha
shivaji nagar,Arninroad, Yavatmal
Wardha
MAHARASHTRA
442001
India |
| Phone |
9922354892 |
| Fax |
07152-287714 |
| Email |
drsahebraokadam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurvedic Medical college,Hospital and Research Center Salod wardha Maharashtra
Datta Meghe Institute of Medical Sciences(Deemed University), Wardha, Nagpur. |
|
|
Primary Sponsor
|
| Name |
Dr Kadam Sahebrao Kishanrao |
| Address |
Mahatma Gandhi Ayurvedic Hospital and Research Center Salod wardha
Maharashtra |
| Type of Sponsor |
Other [other Ph.D research scholar ] |
|
|
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 Kadam sahebrao kishanrao |
Mahatma Gadhi Ayurved Hospital and research center salod wardha |
Mahatam Gandhi Ayurvedic Hospital and research center,department of panchakarma room no 24
Wardha
MAHARASHTRA |
9922354892
07152-287714
drsahebraokadam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Medical Sciences (Deemed University),IntitutionalEthicsCommittee,sawangi (Meghe)wardha-442004 maharashtra India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J454||Moderate persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Jeemutaka and Ikshwaku vamana |
Jeemutaka vamana - jeemutak churna 3.5 gms + saindhava 1.75 gm + madhu 15ml
Ikshwaku vamana - Ikshwaku churna 3.5 gms +saindhava 1.75 gms + madhu 15 ml. Vamanopag dravya 4.5 ltrs Yasthimadhu fanta and 1 ltrs saindhava jala. dhoompan will given by dhoomvarti made by haridra,vacha and suthi churna samsarjana krama will advice for 3 days.
|
| Intervention |
Madanaphala vamana |
Madanaphala vamana - Madanaphala churna 3.5 gms + saindhava 1.75 gm + madhu 15ml. Vamanopag dravya 4.5 ltrs Yasthimadhu fanta and 1 ltrs saindhava jala. dhoompan will given by dhoomvarti made by haridra,vacha and suthi churna samsarjana krama will advice for 3 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
patients presenting with Tamakshwasa (Bronchial asthma)[ICD10-j45.9]
Asthamatic bronchitis NOS
Late-onset asthma |
|
| ExclusionCriteria |
| Details |
patients ages below 20 and above 50 years
patients suffering from any complications or chronic illness
pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation and comparison of Madanaphala,Jeemutaka and Ikshwaku Vamana in Tamakshwasa |
5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To access the Madanaphala Vamana in Tamakshwasa |
5 days |
| Ta access the Jeemutaka and Ikshwaku Vamana in Tamakshwasa |
5 days |
| To compare the Efficacy of Madamanaphala Vamana with Jeemutaka and Ikshwaku Vamana in Tamakshwasa |
5days |
| To find out the relative early clinical and biological improvement between treatment groups |
5days |
| To measure the incidence of adverse events, adverse drug reactions, safety,objective parameters(pft), lab parameters (haematology) and vital during the study |
5 days |
|
|
Target Sample Size
|
Total Sample Size="110"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
12/07/2020 |
| 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 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)?
|
|
Brief Summary
|
This study is a randomized open labelled, prospective comparitive clinical study of phD Research work , to evaluate the effect of Madanaphala,Jeemutaka and Ikshwaku Vamana in Tamakshwasa (Bronchial asthma) . In the Ayurvedic classics Amashaya (stomach) is the sthan of kapha . the first line of treatment of kapha is Vamana . Hence to study the Vamana Karma efficacy. the present topic is taken for the research trial. In present study madanaphala churna ,Jeemutaka churna and Ikshwaku churna for vamana after one day abhyantar snehapana then next day sthanik snehana svedana and then vamana karma in the tamakshwasa and secondary outcome will be measure for assement of efficacy and comparison of madanaphana, jeemutaka and ikshwaku Vamana in tamakshwasa |