| CTRI Number |
CTRI/2025/09/095444 [Registered on: 29/09/2025] Trial Registered Prospectively |
| Last Modified On: |
26/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use Of Katphaladi Kwatha In Bronchial Asthma |
|
Scientific Title of Study
|
Role Of Katphaladi Kwatha In Tamaka Shwasa(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 |
Pooja Bhatt |
| Designation |
PG Scholar(Kaya Chikitsa) |
| Affiliation |
Rishikul Campus Haridwar Uttarakhand Ayurved University (Dehradun) Haridwar |
| Address |
O.P.D No 1, P.G.Department of Kaya Chikitsa Rishikul Campus Haridwar Uttarakhand Ayurved University (Dehradun) Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
8171471228 |
| Fax |
|
| Email |
bhattpooja70@gmail,com |
|
Details of Contact Person
Scientific Query
|
| Name |
ProfDr S K Tripathi |
| Designation |
Professor(Kaya Chikitsa) |
| Affiliation |
Rishikul Campus Haridwar Uttarakhand Ayurved University (Dehradun) Haridwar |
| Address |
O.P.D No 1, P.G.Department of Kaya Chikitsa Rishikul Campus Haridwar Uttarakhand Ayurved University (Dehradun) Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9568004650 |
| Fax |
|
| Email |
sanjaytripathi.460@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pooja Bhatt |
| Designation |
PG Scholar(Kaya Chikitsa) |
| Affiliation |
Rishikul Campus Haridwar Uttarakhand Ayurved University (Dehradun) Haridwar |
| Address |
O.P.D No 1, P.G.Department of Kaya Chikitsa Rishikul Campus Haridwar Uttarakhand Ayurved University (Dehradun) Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
8171471228 |
| Fax |
|
| Email |
bhattpooja70@gmail,com |
|
|
Source of Monetary or Material Support
|
| Rishikul Campus, Uttarakhand Ayurveda university, Haridwar, 249401, India |
|
|
Primary Sponsor
|
| Name |
Uttarakhand Ayurved University Dehradun |
| Address |
Uttarakhand Ayurved University, Station Road, Harrawala, Dehradun-248001 |
| 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 Pooja Bhatt |
Rishikul campus, Uttarakhand Ayurved University Haridwar |
O.P.D NO.1 Deptt of kayachikitsa,Rishikul campus,Uttarakhand Ayurved University,Haridwar Uttarakhand 249401 India Hardwar
Hardwar
UTTARANCHAL |
8171471228
bhattpooja70@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rishikul Campus Haridwar Uttarakhand Ayurved University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J708||Respiratory conditions due to other specified external agents. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Katphaladi kwatha, Reference: Sharangdhara Samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Katphaladi kwatha, Reference: Sharangdhara Samhita madhyam khand 2/43, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Day(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Mild intermittent, mild persistent, moderate persistent asthma according to GINA guidelines.
2.Blood oxygen saturation greater than 90 percent.
3.PEFR greater than 100 litre per min. |
|
| ExclusionCriteria |
| Details |
1.Severe persistent asthma cases according to GINA guidelines.
2.History of tuberculosis, COPD, Emphysema, other complicated disorders.
3.PEFR less than 100 litre per min.
4.Blood oxygen saturation less than 90 percent. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in subjective parameters
1.Parshva shoola
2.Kapha nishthevana
3.Asino labhate saukhyam
4.Shwasakrichta
5.Kanthoudhwanasa
6.Kasa
7.Anidra
8.Pinasa
9.Vishushkaasyata
10.Ushnaabhinanditi |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in objective parameters
1.PEFR
2.Percent of oxygen saturation.
3.ESR
4.AEC |
6 weeks |
|
|
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)
|
15/10/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 is a pranavaha sroto vikara caused by vitiated kapha and vata. It is of five types.Tamaka shwas has similar manifestations as Bronchial Asthma mentioned in modern science.Asthma is an inflammatory disorder of the airway, presenting with airway hyper responsiveness, recurrent episodes pf breathlessness, wheezing,chest tightness and coughing particularly at night and in the early morning.The disease is chronic, episodic, with variable airflow obstruction within the airways which is often reversible, either spontaneously or with treatment.The current management of Tamaka shwaas by modern medicine is not permanent as it provides short symptomatic relief.In present scenario ayurveda is the best way to treat the disease effectively without any adverse effects and safely manage the the condition without any drug dependency. Katphaladi kwatha contains drugs which are kappa and data shamaka and does agnideepaka thereby removing the obstruction from the airways |