| CTRI Number |
CTRI/2026/01/102023 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [karnavedhana therapy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Two Ayurvedic Therapies Along with Herbal Medicine in the Treatment of Bronchial Asthma |
|
Scientific Title of Study
|
A comparative clinical study on effect of Vamana Karma and Karna Vedhana therapy along with Kulatthadi Kwatha in the management Of Tamaka Shwasa 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 |
Ankit Patel |
| Designation |
MD Scholar |
| Affiliation |
Faculty of Ayurveda Banaras hindu University varanasi |
| Address |
Department of kayachikitsa FOA IMS BHU Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9713626496 |
| Fax |
|
| Email |
ankitgound092@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
profRajendra Prasad |
| Designation |
professor |
| Affiliation |
Faculty of Ayurveda Banaras hindu University varanasi |
| Address |
Department of kayachikitsa FOA IMS BHU Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9411471910 |
| Fax |
|
| Email |
rajendraprasad051@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
profRajendra Prasad |
| Designation |
professor |
| Affiliation |
Faculty of Ayurveda Banaras hindu University varanasi |
| Address |
Department of kayachikitsa FOA IMS BHU Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9411471910 |
| Fax |
|
| Email |
rajendraprasad051@gmail.com |
|
|
Source of Monetary or Material Support
|
| department of kayachikitsa BHU varanasi 221005 |
| department of medicinal chemistry BHU varanasi 221005 |
| DEPARTMENT OF PANCHKARMA BHU varanasi 221005 |
|
|
Primary Sponsor
|
| Name |
Banaras Hindu University |
| Address |
Lanka,BHU varanasi 221005 |
| 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 |
| ANKIT PATEL |
Sir sunderlal hospital |
room no 22,department of kayachikitsa BHU VARANASI
Varanasi
UTTAR PRADESH |
9713626496
ankitgound092@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSITITUTIONAL ETHICS COMMITTEE OF BANARAS HINDU UNIVERSITY |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: kulatthadi kwatha, Reference: yogratnakar, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Procedure | - | vedhana-karma, वेधन-कर्म | (Procedure Reference: sushrut sutrasthan 16/3, Procedure details: Karna Vedhana procedure is done at the external ear(particularly at concha) by pointed silver needle 15
• Left ear generally preferred for the procedure as it is more convenient for right handed physician and vice versa
•Patient is to be prepared mentally for the procedure by convincing him for karna Vedhana
•Written consent form is to be signed by him/her before procedure.)
| | 3 | Comparator Arm | Procedure | - | vamanakarma, वमनकर्म | (Procedure Reference: charaka siddhisthana, Procedure details: Snehana Svedana followed by Vamana Karma)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.
Patients willing to participate in the study.
2.
Patients of either sex with age between 18-60 years.
3.
Patients with history of Tamaka Shwasa less than 5 years.
4.
Patients presenting with classical features of Tamaka aShwasa.
5.
Peak flow meter rate more than 80 lit/min and less than 300 lit/min
6.
FVC (Forced Vital Capacity) and FEV1 (Forced Expiratory volume in one second) more than 60% and less than 80%.
7.
FEV1/FVC ratio more than 5% and less than 20%
|
|
| ExclusionCriteria |
| Details |
1.Patients not willing to participate in the study.
2.
Patients of either sex below 18 years & above 60 years will be excluded from the study.
3.
Patient with history of Tamaka Shwasa more than 5 years.
17
4.
Pregnant and lactacting women.
5.
Emphysema
6.
Bronchial Carcinoma
7.
Pleural Effusion.
8.
Tuberculosis.
9.
Neurological disorders like epilepsy, heamorrhagic stroke, meningitis.
10.
Psychological disorders
11.
Status Asthmaticus
12.
Diabetes mellitus
13.
Hypertensive patient
14.
Occupational asthma, Cardiac Asthma.
15.
Emergency patients requiring O2 inhalation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes/ Relief in subjective and objective parameter for Tamaka Shwasa. |
4 weeks,8 weeks,12weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Depending upon subjective & objective parameter, assessment of response will be made based on Gradation Index mentioned before & after treatment.
Grading of assessment criteria of main symptoms described in Ayurvedic texts & modern texts.
Statistical analysis will be made using ‘t’ & ‘F’ test. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
10/02/2026 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
a total number patient will be taken for study is 60. it is divided in two groups each of 30 patients. Group A will be recieving vamana karma along with kullatthadi kwatha and group B will having karna vedhana with same kwatha in tamaka shwasa. |