| CTRI Number |
CTRI/2026/01/101453 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Role of Marichyadi Syrup and Marichyadi Lozenges in the management of cough. |
|
Scientific Title of Study
|
A double arm open label comparative clinical trial on Marichyadi Syrup and Marichyadi Lozenges dosage forms for managing Kasa with special reference Acute Bronchitis in children. |
| 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 Suniti Kumari |
| Designation |
MD Scholar |
| Affiliation |
State Ayurvedic college and hospital Lucknow |
| Address |
P. G. Dept. Of Kaumarabhritya OPD No 1 State Ayurvedic College and hospital, Lucknow Lucknow 226003 UTTAR PRADESH India
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
07985283402 |
| Fax |
|
| Email |
sunitik25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Narayan Gupta |
| Designation |
Professor |
| Affiliation |
State Ayurvedic college and hospital Lucknow |
| Address |
P. G. Dept. Of Kaumarabhritya OPD No 1 State Ayurvedic College and hospital, Lucknow Lucknow 226003 UTTAR PRADESH India
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9415447523 |
| Fax |
|
| Email |
mngupta75@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahesh Narayan Gupta |
| Designation |
Professor |
| Affiliation |
State Ayurvedic college and hospital Lucknow |
| Address |
P. G. Dept. Of Kaumarabhritya OPD No 1 State Ayurvedic College and hospital, Lucknow Lucknow 226003 UTTAR PRADESH India
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9415447523 |
| Fax |
|
| Email |
mngupta75@yahoo.com |
|
|
Source of Monetary or Material Support
|
| State Ayurvedic College and Hospital, tudiyaganj, Tulsidas marg lucknow, Uttar Pradesh 226003 |
|
|
Primary Sponsor
|
| Name |
State Ayurvedic college and hospital Lucknow |
| Address |
PG department of Kaumarbhritya OPD no.1 State Ayurvedic College and hospital lucknow Turiyaganj, Tulsidas marg, Lucknow, Uttar Pradesh |
| 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 Suniti Kumari |
State Ayurvedic Medical college and Hospital, Lucknow |
PG Dept. of kaumarabhritya OPD NO 01 State Ayurvedic College and Hospital, Lucknow UTTAR PRADESH 226003 India
Lucknow
UTTAR PRADESH |
7985283402
sunitik25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee State Ayurvedic College and hospital, Lucknow |
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: Marichyadi Syrup, Reference: Bhavprakash Madhyamkhand Kasaroga adhyaya (39-40), Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 32(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Marichyadi Lozenges, Reference: Bhavprakash Madhyamkhand Kasaroga adhyaya (39-40), Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2000(mg), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects irrespective of gender, religion, socioeconomic status and between the age group of 6-15 years.
2. Acute kasa from day 1 to 3 weeks with or without presence of mucus will be enrolled.
3. Mild fever (37.5 degree celcius to 38.5 degree celcius or 99.5 degree fahrenheit to 101.4 degree fahrenheit should will be enrolled. |
|
| ExclusionCriteria |
| Details |
1. Patient below age of 6 years and above 15 years should be excluded from the study.
2. High grade fever above 38.5 degree celcius or 101.4 degree fahrenheit should be excluded.
3. Patient having Kasa as upadrava or anubandha lakshana (complication) of other systemic disease.
4. Patient suffering from any severe disease of lower respiratory tract infection. Any chronic illness disease of respiratory system eg. TB, Chronic lung disease, Bronchiectasis, Pleurisy which is known.
5. Serious cardiovascular, cerebrovascular, renal and liver disease or severe illness. Patient suffering from any systemic disorder( like Diabetes Mellitus).
6. Children with any congenital abnormality.
7. During course of treatment if the subject develops any acute illness requiring acute managem ent, such patients will be excluded out of the study and continued with conventional treatment.
8. Patients/parents who are not willing to continue the treatment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in the symptoms of the children after 14 days of the trial. |
After completing 14 days of the clinical trial. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Access the efficacy of trial medicine and Improvement in all the symptoms and quality of life of children in 21 days of trial. |
After completing 21 days of the clinical trial. |
|
|
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 1 |
|
Date of First Enrollment (India)
|
01/02/2026 |
| 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="0"
Months="0"
Days="21" |
|
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
|
The present study is a double-arm, open-label, comparative clinical trial undertaken to evaluate the efficacy of Marichyadi Syrup and Marichyadi Lozenges in the management of Kasa, with special reference to Acute Bronchitis in children. In Ayurveda, Kasa is considered a primary disorder of the Pranavaha Srotas and closely correlates with acute bronchitis described in modern medicine. Cough is one of the most common presenting complaints in pediatric practice and, if persistent, may interfere with the normal growth and development of children. Conventional antitussive therapies are often associated with adverse effects and limited acceptability in children, highlighting the need for safer alternatives.
A total of 60 pediatric patients aged 6–15 years will be randomly divided into two groups. Group A will receive Marichyadi Syrup at a dose of 0.8 ml/kg/day, while Group B will receive Marichyadi Lozenges at 50 mg/kg/day, administered for 14 days with 4 follow-up with medicine and one followup without medicine up to 21 days. Both formulations contain Maricha, Pippali, Dadima Twaka, Guda, and Yavakshara, which possess Kasahara, Kaphavata-shamaka, anti-inflammatory, antimicrobial, and immunomodulatory actions.
Clinical assessment will be based on subjective parameters such as cough severity, sputum consistency, wheezing, fever, hoarseness of voice, and dryness of mouth, along with objective investigations including CBC, AEC, and chest X-ray. Statistical analysis will be carried out using paired and unpaired t-tests to compare therapeutic efficacy. This study aims to scientifically validate effective, safe, and child-friendly Ayurvedic dosage forms for pediatric acute bronchitis.
|