| CTRI Number |
CTRI/2026/02/104024 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
14/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare two Ayurvedic medicines (Panchmooladi syrup and Shati compound syrup) in the management of Vataja Kasa among children aged 3 to 10 years. |
|
Scientific Title of Study
|
A randomized comparative clinical study to evaluate the efficacy of Panchmooladi Syrup and Shati Compound in the management of Vataja Kasa among children aged 3 to 10 years. |
| 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 Harshal Prakash Kamble |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurved and Research Centre, Nigdi, Pune |
| Address |
PDEAs College of Ayurved and Research Centre Balrog Department, Nigdi, Pune Maharashtra 411044, India
Pune
MAHARASHTRA
411044
India |
| Phone |
9130653964 |
| Fax |
|
| Email |
harshalkamble06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa Khasgiwala |
| Designation |
Assistant Professor |
| Affiliation |
PDEAs College of Ayurved and Research Centre, Nigdi, Pune |
| Address |
PDEAs College of Ayurved and Research Centre Balrog Department, Nigdi, Pune Maharashtra 411044, India
Pune
MAHARASHTRA
411044
India |
| Phone |
9890077765 |
| Fax |
|
| Email |
drdeepajain@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepa Khasgiwala |
| Designation |
Assistant Professor |
| Affiliation |
PDEAs College of Ayurved and Research Centre, Nigdi, Pune |
| Address |
PDEAs College of Ayurved and Research Centre Balrog Department, Nigdi, Pune Maharashtra 411044, India
Pune
MAHARASHTRA
411044
India |
| Phone |
9890077765 |
| Fax |
|
| Email |
drdeepajain@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Centre Sector 25, Pradhikaran, Nigdi, Pune, Maharashtra, 411044, India |
|
|
Primary Sponsor
|
| Name |
PDEAs College of Ayurved and Research Centre Nigdi, Pune |
| Address |
PDEAs College of Ayurved and Research Centre Sector 25, Pradhikaran, Nigdi, Pune, 411044 |
| 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 Harshal Kamble |
Ayurved Rugnalaya and Sterling Multispeciality Hospital Nigdi Pradhikaran Pune |
Ayurved Rugnalaya and Sterling Multispeciality Hospital Nigdi Pradhikaran Pune Pradhikaran Pune sector 27 Balrog Department OPD No. 118 Pune
Maharashtra
Pune
MAHARASHTRA |
9130653964
harshalkamble06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chairperson Instititional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J00-J06||Acute upper respiratory infections. Ayurveda Condition: VATAJAKASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Shati Compound Syrup, Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 0.6(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -The dose in children is given according to the body weight; hence, the given dose is 0.6 ml per kg per day | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Panchmooladi Syrup, Reference: Yogaratnakar, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 0.6(ml), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -The dose in children is given according to the body weight; hence, the given dose is 0.6 ml per kg per day |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1) Subjects having any two or more classical signs and symptoms of Vataja Kasa, including shushka Kasa described in the context of Vataja Kasa, such as Shushka Kasa, Shirashoola, Swarabheda, Parshwashoola, Uroshoola, Shushka mukha, and gala.
2) Subjects between the age group of 3 to 10 years irrespective of gender, religion, or socioeconomic status will be taken.
3) Subjects having Kasa with symptoms for less than 7 days duration. |
|
| ExclusionCriteria |
| Details |
1) Kasa as Anubandha Lakshan in other systemic diseases.
2) Patients presenting with symptoms of Tamaka Shwasa (bronchial asthma).
3) Kasa associated with Jwara.
4) Known case of pneumonia, emphysema, diphtheria, pertussis, obstructive bronchitis, bronchiectasis, lung abscess, and pulmonary edema resulting from cardiac and renal diseases.
5) Known case of Kochs, HIV, and other debilitating diseases.
6) Known case of congenital anomalies of the respiratory system. |
|
|
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 compare the efficacy of Panchmooladi syrup and Shati compound in the management of Vataj Kasa in children aged 3 to 10 years over 7 days |
7 Days, where Follow up will be on the 3rd, 5th, and 7th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the adverse effects if any |
7 Days, where Follow up will be on the 3rd, 5th, and 7th day. |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
28/02/2026 |
| 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="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
|
Cough is one of the most common symptoms of respiratory tract infection. It is one of the most common reasons that lead to frequent hospital visits. Cough is an important defense mechanism, but persistent cough interferes with sleep and feeding. It fatigues the child. In Ayurved, cough is correlated with Kasa. Cough may be a symptom according to modern medicine, but from an ayurvedic point of view, Kasa is a disease. In Ayurveda, there are five types of Kasa: Vataj, Pittaj, Kaphaj, and Kshtaj. The Prana Vayu and Udan Vayu are responsible for the normal functioning of Pranvaha strotas. The vitiation of Prana Vayu and Udan Vayu causes the manifestation of the Kasa. Vataj kasa is characterized by Shushka gala and mukh, Shushka Kasa, Shirshoola, Parshwashoola, Swarbhed and Uroshoola. Management of Kasa in children needs more care and observation since the complications can make the condition worse in the advance stage of the disease. Vataj Kasa resembles a dry cough. The persistent nature of cough and associated symptoms hampers the daily routine activities of life. In modern medicine antitussive treatment is commonly referred antihistamines; decongestants are also used to treat symptoms. Ayurved offers safe and effective remedies with minimal side effects. Many herbal compositions for Kasa are documented in Ayurveda. While Panchmooladi Kwatha, addressed in Yogratnakar, has been specifically mentioned in the management of Vataj Kasa. Also, according to Charak Samhita, mild, sweet, and palatable medicines should be used in children. So opted for Panchmooladi Syrup formulation. |