| CTRI Number |
CTRI/2022/07/043739 [Registered on: 05/07/2022] Trial Registered Prospectively |
| Last Modified On: |
23/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of Pipaladi leha in Tamak Shwasa (Bronchial asthama) |
|
Scientific Title of Study
|
Clinical evaluation of Pipaladi Leh in Tamak Shwasa |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anup Kumar Gakkhar |
| Designation |
Professor |
| Affiliation |
Rishikul Campus Uttarakhand Ayurveda University Haridwar |
| Address |
OPD no 10 Rishikul Campus Uttarakhand Ayurved University Haridwar Uttarakhand 249401
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9410982602 |
| Fax |
|
| Email |
anupgakkhar@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anup Kumar Gakkhar |
| Designation |
Professor |
| Affiliation |
Rishikul Campus Uttarakhand Ayurveda University Haridwar |
| Address |
OPD no 10 Rishikul Campus Uttarakhand Ayurved University Haridwar Uttarakhand 249401
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9410982602 |
| Fax |
|
| Email |
anupgakkhar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohar |
| Designation |
PG Scholar |
| Affiliation |
Rishikul Campus Uttarakhand Ayurveda University Haridwar Uttarakhand |
| Address |
OPD no 10 Rishikul Campus Uttarakhand Ayurved University Haridwar Uttarakhand 249401
Hardwar
UTTARANCHAL
249401
India |
| Phone |
7015619316 |
| Fax |
|
| Email |
moharlather@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD no 10 and IPD, Department of Kaumarbhritya,Rishikul Campus Uttarakhand Ayurved University Haridwar Uttarakhand 249401 |
|
|
Primary Sponsor
|
| Name |
Uttarakhand Ayurveda University |
| Address |
Uttarakhand Ayurveda University Harrawala Dehradun |
| Type of Sponsor |
Government 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 |
| Dr Mohar |
Rishikul Campus Haridwar |
OPD no 10 and IPD of Kaumarbhritya Department
Hardwar
UTTARANCHAL |
7015619316
Moharlather@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Pipaladi Leh, Reference: Kashyap Samhita Khil sthana 10/136, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 7(g), Frequency: qid, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: Exact dose will be calculated using Young Formula |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1. Children diagnosed as the case of Tamak Shwasa with the presenting symptoms.
2. Mild and moderate asthama according to Global Initiative for Asthama (GINA) guidelines. |
|
| ExclusionCriteria |
| Details |
1. Below the age of 6years and above the age of 14 years.
2. severe Asthama according to the Global Initiative for Asthama (GINA) guidelines. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
it will be assessed based on following parameters-
1. Relief in difficulty in breathing
2. Relief in intensity of cough
3. Relief in Rhinitis intensity
4. improvement in Disturbed sleep
5. Relief in frequency of Shwasa Vega |
It will be assessed every 2nd week for 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Exacerbation in sign and symptoms
2. Improvement in Peak Expiratory Flow Rate |
It will be assessed every 2nd week for 2 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
08/07/2022 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Tamak shwasa is a type of breathing disorder. It can be correlated with Bronchial asthama as per modern science. This study trial drug Pipaladi Leh for orally intake. This study aim to evaluate the efficacy of Pipaladi Leh in Tamak shwasa and management of Tamak shwasa. Duration of treatment is 60days. Patients will be take OPD no 10 PG Department of Kaumarbhritya, Rishikul Campus, Haridwar, Uttarakhand Ayurveda University Harrawala Dehradun |