| CTRI Number |
CTRI/2026/02/103284 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
06/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare Efficacy between Shatmuli Kwath and Kantakari Ghrita in the management of Vataj Kasa. |
|
Scientific Title of Study
|
A Randomised comparative clinical trial to evaluate the efficacy of Shatamuli Kwath and Kantakari Ghrita in the management of Vataj Kasa |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyanka Maruti Shinde |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurveda and research centre, nigadi pradhikaran, pune |
| Address |
3 rd floor, kayachikitsa department, PDEAs College of Ayurveda and research centre, nigadi pradhikaran, pune
MAHARASHTRA Pune 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
9067767690 |
| Fax |
|
| Email |
priyankashinde1387@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRupali T Khobragaade |
| Designation |
HOD & Professor Kayachikitsa Department |
| Affiliation |
PDEAs College of Ayurveda and research centre, nigadi pradhikaran, pune |
| Address |
3 rd floor, kayachikitsa department, PDEAs College of Ayurveda and research centre, nigadi pradhikaran, pune
MAHARASHTRA Pune 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
8378929859 |
| Fax |
|
| Email |
khobragaderupali19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRupali T Khobragaade |
| Designation |
HOD & Professor Kayachikitsa Department |
| Affiliation |
PDEAs College of Ayurveda and research centre, nigadi pradhikaran, pune |
| Address |
3 rd floor, kayachikitsa department, PDEAs College of Ayurveda and research centre, nigadi pradhikaran, pune
MAHARASHTRA Pune 411044
MAHARASHTRA
411044
India |
| Phone |
8378929859 |
| Fax |
|
| Email |
khobragaderupali19@gmail.com |
|
|
Source of Monetary or Material Support
|
| 3rd floor, Kayachikitsa department , Pdeas College of Ayurveda and Research Centre , Nigadi, Pradhikaran, Pune
Maharashtra , Pune 411044 |
|
|
Primary Sponsor
|
| Name |
PDEAs College of Ayurveda and research centre, Nigadi Pradhikaran, Pune |
| Address |
PDEAs College of Ayurveda and research centre nigdi, pradhikaran, pune |
| 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 |
| Dr Priyanka Maruti Shinde |
Dr Priyanka Maruti Shinde |
117A,kayachikitsa department,ayurved Rugnalaya and snowbell multispeciality hospital nigadi pradhikaran, pune
MAHARASHTRA Pune 411044
INDIA
Pune
MAHARASHTRA |
9067767690
priyankashinde1387@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PDEAs College Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients of age between 19 - 60 years with Vataj Kasa. |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shatamuli Kwath, Reference: Harita Samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -Koshna Jal), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kantakari Ghrita, Reference: Charak Chikitsa, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -Koshna Jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with presenting symptoms of Vataj Kasa, like-
1] Shushka kasa,
2] Hritshool,
3] Parshvashool,
4] Shirashool
5] Swarbhed
Minimum 3 out of 5 symptoms with a history of more than 3
days.
• Patients in the age group between 19-60 years.
• Patients irrespective of gender, caste, income group, and
occupation |
|
| ExclusionCriteria |
| Details |
Patients with suspected cases and known cases of Tuberculosis,
2. Patients with Known case/History of –
1. Bronchitis
2. Bronchiectasis
3. Chronic obstructive pulmonary disease
4. Emphysema
5. Pneumonia
6. Lung Cancer
7. pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduced Vataj Kasa symptoms |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe adverse effect , if any |
21days
follow up of 7 days |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
01/03/2026 |
| 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="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
|
In today’s era, many population is exposed to smoking, exposure to cold and dry air (sitting in AC for a long time), and Occupational hazards like chemical fumes, metallic dust, which causes pranvaha strotas dushti leading to Vataj Kasa. This study aims to scientifically evaluate and compare the therapeutic efficacy of Shatamuli kwath and Kantakari Ghrita in adult patients suffering from Vataj Kasa, thereby promoting evidence-based use of Ayurveda. Vataj Kasa is common, especially during seasonal changes like cold and dry weather in Vata-predominant individuals. Shatamuli Kwath: Vata-pacifying, rasayana traditionally used in respiratory disorders. Kantakari Ghrita: Ghee-based, antiallergic, anti-inflammatory, classically indicated, and proven drug for Vataj Kasa.Kantakari is a proven drug in Vataj Kasa. But no study has been done on shatamuli kwath |