| CTRI Number |
CTRI/2025/10/095965 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
12/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Check Efficacy Of Agasti Modak And Sitopaladi Churna On Productive Cough In Pediatric Age(3-11yrs) Group |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Efficacy Of Agasti Modak And Sitopaladi Churna In The Management Of Kaphaj Kasa In Pediatric Age Group |
| 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 Yamuna |
| Designation |
PG Scholar |
| Affiliation |
Shri Narayana Prasad Awasthi Government Ayurved College Raipur |
| Address |
Departmnent of Kaumarbhritya OPD NO.10 & IPD Patients
Shri khudadad Dungaji Government Ayurved Hospital Raipur chhattisgarh 492010 India
Raipur
CHHATTISGARH
492010
India |
| Phone |
7828506736 |
| Fax |
|
| Email |
Saoyamuna55@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Neeraj Agrawal |
| Designation |
Professor and HOD |
| Affiliation |
Shri Narayana Prasad Awasthi Government Ayurved College Raipur |
| Address |
Departmnent of Kaumarbhritya
Shri Narayana Prasad Awasthi Government Ayurved College Raipur chhattisgarh 492010 India
Raipur
CHHATTISGARH
492010
India |
| Phone |
9109923485 |
| Fax |
|
| Email |
dr_neeraj2001in@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anju Chandrakar |
| Designation |
Lecturer |
| Affiliation |
Shri Narayana Prasad Awasthi Government Ayurved College Raipur |
| Address |
Departmnent of Rasashastra evam Bhaishajya kalpana
Shri Narayana Prasad Awasthi Government Ayurved College Raipur chhattisgarh 492010 India
Raipur
CHHATTISGARH
492010
India |
| Phone |
9406247034 |
| Fax |
|
| Email |
dr.anjuchandrakar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Kaumarbhritya Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010 |
|
|
Primary Sponsor
|
| Name |
Department Of Kaumarbhritya Shri Narayan Prasad Awasthi Government Ayurved College Raipur CG |
| Address |
Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010 |
| Type of Sponsor |
Other [Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Shri Narayan Prasad Awasthi Government Ayurved College Raipur |
Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Yamuna |
Shri khudadad Dungaji Government Ayurved Hospital Raipur chhattisgarh 492010 |
OPD NO.10 & IPD
Departmnent of Kaumarbhritya
Shri khudadad Dungaji Government Ayurved Hospital Raipur chhattisgarh 492010
Raipur
CHHATTISGARH |
7828506736
Saoyamuna55@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE GOVERNMENT AYURVED COLLEGE RAIPUR |
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: AGASTI MODAK, Reference: Bhaisajyaratnavali / AFI volume 3 pg no 42-43, Route: Oral, Dosage Form: Modaka , Dose: 2(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 10 Days, anupAna/sahapAna: No, Additional Information: Dose according to age/TID
3-5yrs -2.5-3.5gm
6-8yrs -3.5-5.5gm
9-11yrs -4.5-6.5gm | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: SITOPALADI CHURNA, Reference: Charak Chikitsa Sthan 8-103/AFI volume1 , Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: Madhu - Ghrita), Additional Information: Dose according to age/TID 3-5yrs - 0.2-0.6 gm 6-8yrs - 0.4-1gm 9-11yrs - 0.5-1.3gm |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either gender from age 3-11 yrs
patients have classical symptoms of kasa
subject willing to participate in study after consent |
|
| ExclusionCriteria |
| Details |
Patients below 3yr and above 11 yrs
Chronic disorders like TB,Pneumonia,RDS,CHD,COPD Pleural effusion
Children with any congenital deformity
Patients on long term medication as any steroids medicine |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Reduce The Symptoms Of Kasa Vega (Frequency Of Cough)
2.Reduce Nisthavati Ghanam Kapham (Productive Cough)
3.Kaphapurna Deha (Heaviness in the body) Reduce |
Intervention Of Medicine For 10th Days And Follow Up On 11th Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improve the quality of life |
At Baseline 10 days of Active intervention |
|
|
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)
|
02/02/2026 |
| 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="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
|
Physiologically, kaphaj dosha is more common in balya-awastha and might result in kaphaj kasa and other kaphaj vyadhi. This is among the most prevalent illnesses that impact Pranvaha shrotas and the child’s overall health. An acute respiratory tract infection is linked to upper respiratory disorders. The study includes pediatric patients diagnosed with Kaphaj Kasa, who are randomly divided into two groupsGroup A (Trial group) will receive Agasti Modak in oral form, three times daily after meals for 10 days. Dose will be adjusted as per age: 2.5 – 3.5 g (3 – 5 yrs), 3.5 – 5.5 g (6 – 8 yrs), and 4.5 – 6.5 g (9 – 11 yrs). Group B (Control group) will receive Sitopaladi Churna with Madhu and Ghrita three times daily after meals for 10 days, with age-appropriate dose ranging from 0.2– 0.6 g (3-5 yrs) , 0.4 - 1 g (6-8 ys) and 0.5-1.3 g (9-11yrs) Follow-up will be done on the 11th day after treatment completion. Assessment will be based on subjective and objective parameters related to the severity and frequency of cough and associated symptoms. Dietary advice (Pathya-Apathya) will be followed during the study.The efficacy of the treatments will be evaluated based on clinical symptoms such as cough frequency, sputum production, and overall improvement in respiratory function. The study seeks to determine which formulation provides better relief and faster recovery, thereby contributing to evidence-based Ayurvedic management of respiratory disorders in children. Agasti Modak is a classical Ayurvedic formulation mentioned in Bhaisajya Ratnawali It is indicated in Kaphaja Kasa (cough). Agasti modak have seven ingredients they act as bronchodilator, expectorant, and immunomodulatory effects. Hence, it helps in reducing frequency and severity of cough, relieving airway obstruction, and promoting clearance of respiratory secretions. |