| CTRI Number |
CTRI/2025/02/081234 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
22/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Bharangyadi Kwath in Management of Tamaka Shvasa / Bronchial Asthma
Ayurvedic treatment ( Bharangyadi Kwath ) in Bronchial Asthma / Tamaka Shvasa |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial to Evaluate the Effect of Bharangyadi Kwath in Management of Tamaka Shvasa with Special Reference to Bronchial Asthma |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MINAL MANOHARRAO KHODE |
| Designation |
PhD Scholar |
| Affiliation |
D.M.M Ayurved Mahavidyalaya, Yavatmal |
| Address |
Hospital of D.M.M. Ayurved Mahavidyalaya, Kayachikitsa Department, OPD Number 10, IPD ROOM NUMBER 29, Yavatmal SH3 Arni Road Shivaji Nagar Yavatmal Maharashtra
Kayachikitsa Department of D.M.M. Ayurved Mhavidyalaya, opd number 10, IPD number 29, Yavatmal
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
08999362177 |
| Fax |
07232-243896 |
| Email |
minalkhode2014@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suryaprakash Jaiswal |
| Designation |
Professor in Kayachikitsa |
| Affiliation |
D.M.M Ayurved Mahavidyalaya, Yavatmal |
| Address |
D.M.M. Ayurved Mahavidyalaya, Yavatmal SH3 Arni Road Shivaji Nagar Yavatmal Maharashtra
Kayachikitsa Department of D.M.M. Ayurved Mhavidyalaya, opd number 10, IPD number 29, Yavatmal
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
9822126706 |
| Fax |
07232-243896 |
| Email |
dr.skjaiswal01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MINAL MANOHARRAO KHODE |
| Designation |
PhD Scholar |
| Affiliation |
D.M.M Ayurved Mahavidyalaya, Yavatmal |
| Address |
D.M.M. Ayurved Mahavidyalaya,Kayachikitsa Department, OPD Number10, IPD number 29, Yavatmal SH3 Arni Road Shivaji Nagar Yavatmal Maharashtra
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
08999362177 |
| Fax |
07232-243896 |
| Email |
minalkhode2014@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hospital of D.M.M. Ayurved Mahavidyalaya Yavatmal Kayachikitsa OPD room no 10 and IPD room no 29 |
|
|
Primary Sponsor
|
| Name |
Dr. Minal Manoharrao Khode |
| Address |
D.M.M. Ayurved Mahavidyalaya, Yavatmal |
| 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 |
| Dr Suryaprakash K Jaiswal |
Hospital of D.M.M. Ayurved Mahavidyalaya, Yavatmal |
Kayachikitsa Department, OPD Number 10, IPD room number 29,SH3 Arni road, shivaji nagar, Yavatmal. pin code 445001
Yavatmal
MAHARASHTRA |
9822126706
07232-243896
dr.skjaiswal01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| D.M.M. Ayurved Mahavidyalaya,Yavatmal Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J453||Mild persistent asthma. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bharangyadi Kwath, Reference: Yogaratnakar Shvasachikitsa Adhyay 6, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: -patients must have to prepare fresh Kwath daily | | 2 | Comparator Arm (Non Ayurveda) | | - | Tablet Doxophylline 200mg one tab bd with water | 200 mg one tablet is given twice a day with water after meal orally for 45 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having respiratory rate in between 22 to 42/minute, chronic patients of bronchial asthma since from 1year to 10 years, mild to moderate bronchial asthma exacerbation according to GINA guideline, positive test of reversibility, showing sign and symptoms of bronchial asthma. |
|
| ExclusionCriteria |
| Details |
patient having hypoxia, severe acute bronchial asthma exacerbation according to GINA guidelines, renal and cardiovascular diseases, malignancy, surgery before 2 weeks, patients discontinue treatment, AIDS, uncontrolled hypertension and diabetes, age less than 18 and more than 70 years, pregnant and lactating mother active lung diseases other than bronchial asthma. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| My primary outcome is Bharangyadi Kwath is effective in management of Tamaka Shvasa in 6 weeks |
My primary outcome is Bharangyadi Kwath is effective in management of Tamaka Shvasa in 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of CBC, ESR, PEFR, SMI, MRC Scale, RR, SPO2, Inspiration time, Expiration time, breath holding time, |
6 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
05/03/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
I Dr. Minal Manoharrao Khode, working as a Ph.D. Scholar since 20/03/21 at D.M.M. Ayurved Mahavidyalaya, Yavatmal. In my Ph.D. study a randomized controlled clinical trial is conducted to evaluate the effect of Bharangyadi Kwath in management of Tamaka Shvasa with special referance to bronchial asthma under guidance of my guide Dr. Suryaprakash Jaiswal. in this study 84 sample size are calculated with considering withdrawal criteria in mind 90 patients taken in each group means total 180 patients are included in this study. This is comparative type of study in which trial group gets Bharangyadi Kwath for 6 weeks and control group treated with tablet Doxophylline for 45 days. The primary aim of study is to evaluate the effect of Bharangyadi kwath in management of Tamaka Shvasa i.e. bronchial asthma. My synopsis got approval by college ethical committee on dated 22/04/22 and my tittle and synopsis get approved by MUHS University on dated 30/11/22. i almost did literary review, drug review, historical review. before starting patients recruitment for my thesis work want CTRI Registration number. so, sir please provide it as early as possible and do needful. |