| CTRI Number |
CTRI/2024/06/068455 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
04/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role Of Efficacy Of Kantakari Ghrita in Vatika Kasa (Dry Cough) |
|
Scientific Title of Study
|
A Clinical Study On Vatika Kasa (Dry Cough)- Role Of Efficacy Of Kantakari Ghrita - An Open Labelled Randomized Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harshil Ghanshyamsinh Padhiyar |
| Designation |
PG Scholar |
| Affiliation |
Government. Akhandanand Ayurved College and Hospital |
| Address |
OPD NO. 4 , Department of Kayachikitsa, Government Akhandanand Ayurved College, Bhadra, Ahmadabad
Ahmadabad GUJARAT 380001 India |
| Phone |
7874598969 |
| Fax |
|
| Email |
harshilpadhiyar72.hp@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Himanshu Kanzaria |
| Designation |
Assistant Professor |
| Affiliation |
Government. Akhandanand Ayurved College and Hospital |
| Address |
OPD NO. 4, Department of Kayachikitsa, Government Akhandanand Ayurved College, Bhadra, Ahmadabad
Ahmadabad GUJARAT 380001 India |
| Phone |
8866579316 |
| Fax |
|
| Email |
drhimen2006@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Himanshu Kanzaria |
| Designation |
Assistant Professor |
| Affiliation |
Government. Akhandanand Ayurved College and Hospital |
| Address |
OPD NO. 4, Department of Kayachikitsa, Government Akhandanand Ayurved College, Bhadra, Ahmadabad
Ahmadabad GUJARAT 380001 India |
| Phone |
8866579316 |
| Fax |
|
| Email |
drhimen@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Akhandanand Ayurved College, Ahmedabad, Gujarat, India. Pincode - 380001 |
|
|
Primary Sponsor
|
| Name |
Government Akhandanand Ayurveda College Ahmedabad |
| Address |
OPD No 4 Department of Kayachikitsa Government Akhandanand Ayurved College Ahmedabad, Gujarat, India. Pincode - 380001 |
| 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 Harshil G Padhiyar |
Government Akhandanand Ayurveda Hospital |
OPD No. 4, Department of Kayachikitsa, Government Akhandanand Ayurveda College, Bhadra, Ahmedabad Ahmadabad GUJARAT |
7874598969
harshilpadhiyar72.hp@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:J069||Acute upper respiratory infection,unspecified. Ayurveda Condition: VATAJAKASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kantakari Ghrita, Reference: Charaka Samhita Kasa Chikitsita, Route: Oral, Dosage Form: Ghrita, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Ushna Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient with complaints of acute cough lessthan 3 weeks.
2. Patients with classical signs and symptoms of Vatika Kasa described in Charaka
Samhita treatise will be selected for present study.
➢ Shushka Kasa (Dry Cough)
➢ Swarabheda (Hoarseness of Voice)
➢ Kshobha (Sore Throat/ Irritation)
➢ Daurbalya (Weakness)
➢ Urashoola (Chest Pain)
|
|
| ExclusionCriteria |
| Details |
1. Red Flag Signs associated with Cough: Hemoptysis, Breathlessness, Weight Loss,
Fever.
2. Patients suffering from the systemic or serious illness like Emphysema, Renal
diseases, Diabetes Mellitus and Cardiovascular diseases.
3. Any acute systemic disease or Infection, with post covid lung disease/complication.
4. Pregnant & lactating mothers.
5. Any Malignancy.
6. Acute and serious conditions which require emergency intervention will be
excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Trial Drug Kantakari Ghrita will do cure of symptoms of Vatika Kasa. (Symptoms - Shushka Kasa, Svarabheda, Kshobha, Daurbalya, Uraha Shoola) |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The Trial Drug Kantakari Ghrita will be effective in improving quality of life in patients
of Vatika Kasa. |
1 week |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
16/06/2024 |
| Date of Study Completion (India) |
24/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="8" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
A Clinical Study On Vatika Kasa (Dry Cough) - Role of Efficacy Of Kantakari Ghrita. This clinical study is designed to address the dry cough of acute nature occuring as a result of upper respiratory tract infection.Dry cough as a result of upper respiratory tract infection remains refractory in nature at many times and can be severe enough to affect daily life style. So this clinical study is undertaken to bridge this gap. |