| CTRI Number |
CTRI/2025/03/082803 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study of Vibhitaka phala churna in the management of Tamaka Shwasa,Bronchial asthma. |
|
Scientific Title of Study
|
To Evaluate The Clinical Effect Of Vibhitaka Phala Churna In The Management Of Tamaka Shwash W.S.R. To Bronchial Asthama |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr Pravin Kharadi |
| Designation |
Professor |
| Affiliation |
Shree Swaminarayan Ayurvedic College,kalol |
| Address |
OPD 004, Department of kayachikitsa, Premswarup Swami Ayurvedic Multispeciality hospital, Teaching Hospital Of Shree Swaminarayan Ayurvedic college, Ahmedabad-Mehsana Highway At and po Saij Ta Kalol Dist Gandhinagar Gujarat.
Gandhinagar
GUJARAT
382721
India |
| Phone |
9978136650 |
| Fax |
|
| Email |
pravinkharadi321@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Pravin Kharadi |
| Designation |
Professor |
| Affiliation |
Shree Swaminarayan Ayurvedic College,kalol |
| Address |
OPD 004, Department of kayachikitsa, Premswarup Swami Ayurvedic Multispeciality hospital, Teaching Hospital Of Shree Swaminarayan Ayurvedic college, Ahmedabad-Mehsana Highway At and po Saij Ta Kalol Dist Gandhinagar Gujarat.
Gandhinagar
GUJARAT
382721
India |
| Phone |
9978136650 |
| Fax |
|
| Email |
pravinkharadi321@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sandipkumar R Rajput |
| Designation |
Pg scholar |
| Affiliation |
Shree Swaminarayan Ayurvedic College,kalol |
| Address |
OPD 004, Department of kayachikitsa, Premswarup Swami Ayurvedic Multispeciality hospital, Teaching Hospital Of Shree Swaminarayan Ayurvedic college, Ahmedabad-Mehsana Highway At and po Saij Ta Kalol Dist Gandhinagar Gujarat.
Gandhinagar
GUJARAT
382721
India |
| Phone |
8884676933 |
| Fax |
|
| Email |
sandeepsinhrajput44@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Swaminarayan Ayurvedic College and Hospital,kalol, Gandhinagar, Gujarat.382721 |
|
|
Primary Sponsor
|
| Name |
Shree Swaminarayan Ayurvedic College, kalol, |
| Address |
Shree Swaminarayan Ayurvedic College and Hospital,kalol, Gandhinagar, Gujarat.382721 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Prof Dr Pravin Kharadi |
Premswarup swami Ayurvedic Multispeciality Hospital,Kalol |
Shree Swaminarayan Ayurvedic college, Ahmedabad-Mehsana Highway At and po Saij Ta Kalol Dist Gandhinagar Gujarat.
Gandhinagar
GUJARAT |
9978136650
pravinkharadi321@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-Shree Swaminarayan Ayurvedic college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J454||Moderate persistent asthma. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vibhitaka Phala Churna, Reference: Chakradatta Hikka-shwasa Adhikar 18, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient fulfilling the diagnostic criteria.
2.Patient having intermittent, mild persistence or moderate persistent type of asthma.
3.Newly diagnosed patients of asthma less than 01 year.
4.Patient having PEFR percentage more than 40 percent. |
|
| ExclusionCriteria |
| Details |
1.Pregnant or lactating woman.
2.Patients suffering from pathological condition like hypertension, carcinoma, left ventricular hypertrophy (LVH), ischemic heart disease (IHD), tuberculosis and diabetes mellitus.
3.Patients having status asthmatics and acute severe exacerbation of asthma or severe persistent asthma were excluded in the present study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Relief in the symptoms of tamaka shwasa.
2.To assess the effect of Vibhitaka Phala Churna with Madhu in the management of Tamaka shwasa,bronchial asthma.
|
28 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the etiopathogenesis,symptomatology and progress of the disease i.e. Nidan
panchaka and predominance of dosha according to ayurvedic classics as well as modern
medical science. |
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)
|
15/04/2025 |
| 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="1"
Months="2"
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
|
Tamaka shwasa, described in Ayurveda,is a respiratory disorder resembling
bronchial asthma.it is characterized by symptoms like wheezing, breathlessness, and coughing. The prevalence of
chronic airway disorders, particularly asthma, has increased globally, with india reporting over 30 million asthma
patients. A major concern is that many patient remain undiagnosed, and the conventional treatment involving
bronchodialators and corticosteroids often has adverse effects.Ayurveda, with its holistic approach, offers a potential solution through natural remedies. One such remedy is
Vibhitaka phala churna.Ayurveda mentions that vibhitaka has ability to balance the doshas, particularly kapha and
vata, and provides relief from respiratory distress by acting as a vata anulomana (promoting proper vata movement)
and kapha-vata hara (balancing kapha and vata doshas). It also acts as anti inflammatory, reducing mucus production
and alleviating symptoms of asthma. The chakra datta recommends the combination of Vibhitaka powder with honey
(Madhu) for effective treatment of tamaka shwasa.
This study aims to assess the effectiveness of Vibhitaka phala churna with madhu in managing tamaka shwasa
(bronchial asthama). The study will involve 30 patients, with a treatment duration of 28 days. The dosage will be
3grams of Vibhitaka powder thrice daily, mixed with honey.
The anticipated outcome is to demonstrate the efficacy of this Ayurvedic formulation in alleviating asthma symptoms.If
successful, this could offer a safe and cost-effective alternative for asthma management.Assessment will be done on the basis of subjective and Objective Criteria and Investigations. |