| CTRI Number |
CTRI/2025/12/098773 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
27/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Katphaladi gummies for the patient of cough |
|
Scientific Title of Study
|
A Comparative Pharmaceutical And Clinical Study Of Katphaladi Kwath And Its Gummy Form In The Management Of Kasa With Special Reference To Cough |
| 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 Abhay Rastogi |
| Designation |
M.D. Scholar |
| Affiliation |
Govt P.G. Ayurveda College and Hospital Chaukaghat Varanasi |
| Address |
3rd floor, Room no. 8, Department of Rasa Shastra Evam Bhaishajya Kalpana, Govt P.G. Ayurveda College and Hospital Chaukaghat Varanasi U.P.221002
Varanasi
UTTAR PRADESH
221002
INDIA
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
7983711180 |
| Fax |
|
| Email |
abhayrastogi51@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Sanjay Kumar Pandey |
| Designation |
Prof and Head of Department of Rasa Shastra Evam Bhaishajya Kalpana |
| Affiliation |
Govt P.G. Ayurveda College and Hospital Chaukaghat Varanasi U.P.221002 Varanasi UTTAR PRADESH |
| Address |
Dept of Rasa Shastra Evam Bhaishajya Kalpana Govt P.G. Ayurveda College and Hospital Chaukaghat Varanasi U.P.221002
Varanasi
UTTAR PRADESH
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9417077401 |
| Fax |
|
| Email |
dr.spandey2007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nitin Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Govt P.G. Ayurveda College and Hospital Chaukaghat Varanasi U.P.221002 Varanasi UTTAR PRADESH |
| Address |
Dept of Kayachikitsa Govt P.G. Ayurveda College and Hospital Chaukaghat Varanasi U.P.221002
Varanasi
UTTAR PRADESH
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9557275726 |
| Fax |
|
| Email |
drnitinsharma7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Rasa Shastra Evam Bhaishajya Kalpana Govt P.G. Ayurveda College and Hospital Chaukaghat Varanasi U.P.221002 |
|
|
Primary Sponsor
|
| Name |
Govt P.G. Ayurveda College and Hospital Chaukaghat Varanasi U.P.221002 |
| Address |
Govt P.G. Ayurveda College and Hospital Chaukaghat Varanasi U.P.221002
Varanasi
UTTAR PRADESH
221002
INDIA |
| 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 |
| Dr Abhay Rastogi |
Govt P.G. Ayurveda College and Hospital Chaukaghat Varanasi U.P.221002 |
Department of Rasa Shastra Evam Bhaishajya Kalpana
Varanasi
UTTAR PRADESH
221002
INDIA
Varanasi
UTTAR PRADESH |
7983711180
abhayrastogi51@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,GOVERNMENTP.G. AYURVEDA COLLEGEAND HOSPITAL,VARANASI,U.P.,MAHAYOGI GURU GORAKHNATH AYUSH UNIVERSITY, GORAKHPUR,U.P. |
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: KASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Katphaladi Kwatha, Reference: SHARANGDHAR SAMHITA MADHYAM KHANDA (2/47), Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: KATPHALADI GUMMIES, Reference: NA, Route: Oral, Dosage Form: Lozenges, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -DOSAGE IN GUMMY FORM
IT IS A KIND OF CHEWABLE TABLET |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants who give consent to participate in the study will be included. Eligible participants must exhibit clinical signs and symptoms of Kasa . Both male and female patients between the ages of 16 and 60 years are eligible, provided they have been experiencing complaints for less than three months. |
|
| ExclusionCriteria |
| Details |
Patients below the age of 16 years or above 60 years will be excluded from the study. Those who have had complaints for more than three months will not be considered. Patients suffering from chronic diseases of the lung, such as COPD, Tuberculosis, CA of the Lung, or known cases of Bronchial Asthma, will also be excluded. Additionally, patients with hypertension and cardiac problems will not be included. Individuals with specific genetic syndromes sometimes associated with Diabetes Mellitus, such as Down Syndrome, Klinefelter Syndrome, and Turner Syndrome, will also be excluded. Systemic disorders such as uncontrolled Hypertension, uncontrolled Diabetes Mellitus, Hypothyroidism, or Hyperthyroidism, as well as pregnant or lactating women, are criteria for exclusion. Lastly, any patient who does not follow medical advice will not be eligible for the study. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in kasa |
7th day,14th day, 21th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complete relief from Kasa |
21th day |
|
|
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 |
|
Date of First Enrollment (India)
|
13/02/2026 |
| 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="2"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Interventional study Patient suffering from Kasa will selected from OPD of government ayurvedic college and hospital chaukaghat varanasi Total patients 60 Group A 30 patient will be treated with katphaladi kwath Group B 30 patients will be treated with katphaladi gummy Treatment plan Duration Of Treatment - The test drug will be given for 14 days to assess its effect. There will be 2 assessment in the middle of treatment as given below Assessment 1- on 7th day. Assessment 2 - on 14th day. Follow Up - At interval of 7th day after completion of drug trial. Total Duration - 14 + 7 = 21 days |