| CTRI Number |
CTRI/2022/03/041321 [Registered on: 23/03/2022] Trial Registered Prospectively |
| Last Modified On: |
21/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of Triphaladi Churnavati In Avegawastha Of Tamakshwas (Bronchial Asthma) |
|
Scientific Title of Study
|
Study of Triphaladi Churnavati In Avegawastha Of 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 Chinmayi Raut |
| Designation |
student |
| Affiliation |
Bharati Vidyapeeth, Dhankawadi, Katraj |
| Address |
2nd floor, New Building, Bharati Vidyapeeth, Dhanakawadi, Katraj.
pin-411043
Pune
MAHARASHTRA
411043
India |
| Phone |
|
| Fax |
|
| Email |
chinmayiraut1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Virendra Pawar |
| Designation |
Assistant Professor |
| Affiliation |
Bharati Vidyapeeth(Deemed to be university) College of Ayurved and Hospital, Katraj, Pune. |
| Address |
BHARATI VIDYAPEETH (DEEMED TO BE UNIVERSITY)COLLEGE OF AYURVED AND HOSPITAL, DHANAKAWDI,PUNE.
Pune
MAHARASHTRA
411043
India |
| Phone |
|
| Fax |
|
| Email |
drvirendra7007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chinmayi Raut |
| Designation |
student |
| Affiliation |
Bharati Vidyapeeth, Dhankawadi, Katraj |
| Address |
2nd floor, New Building, Bharati Vidyapeeth, Dhanakawadi, Katraj.
pin-411043
Pune
MAHARASHTRA
411043
India |
| Phone |
|
| Fax |
|
| Email |
chinmayiraut1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| BHARATI VIDYAPEETH (DEEMED TO BE UNIVERSITY)COLLEGE OF AYURVED AND HOSPITAL, DHANAKAWADI, PUNE. |
|
|
Primary Sponsor
|
| Name |
Dr Chinmayi Raut |
| Address |
BHARATI VIDYAPEETH(DEEMED TO BE UNIVERSITY)COLLEGE OF AYURVED AND HOSPITAL, DHANAKAWADI,KATRAJ, PUNE. |
| 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 CHINMAYI RAUT |
BHARATI VIDYAPEETH(DEEMED TO BE UNIVERSITY)COLLEGE OF AYURVED AND HOSPITAL, DHANAKAWADI, PUNE. |
BHARATI VIDYAPEETH(DEEMED TO BE UNIVERSITY)COLLEGE OF AYURVED AND HOSPITAL, DHANAKAWADI, PUNE.
Pune
MAHARASHTRA |
8007401284
chinmayiraut1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BV(DU)COA-EC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J459||Other and unspecified asthma. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: TRIPHALADI CHURNAVATI, Reference: BHARAT BHAISHAJYA RATNAKAR, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1.5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -KOSHNA JALA), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having signs and symptoms of Avegawastha of Tamakshwas explained in Ayurvedic texts.
Patients of age group 18 years to 70 years.
Patients having signs and symptoms of Bronchial Asthma explained in Modern text.
|
|
| ExclusionCriteria |
| Details |
Patients having age less than 18 years and age beyond 70 years.
Patients having complications like haemoptysis, cardiac diseases like Chronic Cardiac Failure, Ischemic Heart disease, Atrial flutter, Atrial fibrillation.
SPO2 less than 90%.
Patients suffering from diseases like Tuberculosis, Malignancy of any part of body, HIV.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| REDUCTION IN SYMPTOMS LIKE BREATHLESSNESS, DIFFICULT TO EXPECTORATE, LIFE THREATING SEVERE BREATHING, CHEST TIGHTNESS IN AVEGAWASTHA OF TAMAKSHWAS. |
28 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| REDUCTION OF SYMPTOMS LIKE WHEEZING SOUND EXAMINED BY AUSCULTATION OF THE LUNGS BY STHETHOSCOPE, DISTURBED SLEEP IN AVEGAWASTHA OF TAMAKSHAWAS. |
28 DAYS |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2 |
|
Date of First Enrollment (India)
|
31/03/2022 |
| 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="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)?
Response - NO
|
|
Brief Summary
|
TRIPHALADI CHURNAVATI USE IN TAMAKSHWAS PATIENT 30 PATIENTS TAKEN FOR STUDY 1.5 GM BEFORE LUNCH AND DINNER FOR 28 DAYS. FOLLOW UP 0N 7,14,21, 28 DAYS. |