| CTRI Number |
CTRI/2026/03/106636 [Registered on: 20/03/2026] Trial Registered Prospectively |
| Last Modified On: |
16/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to evaluate the effect of Shrungyadi Churna in treating rhinitis in children |
|
Scientific Title of Study
|
Randomized controlled clinical trial to evaluate the efficacy of shrungyadi churna in the management of pratishaya 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 Nikhil Vishnu Randave |
| Designation |
PG Scholar |
| Affiliation |
CSMSS Ayurveda Mahavidyalaya and Rugnalaya 431002 Chh. Sambhajinagar |
| Address |
OPD No. 14 Kaumarbhritya department, C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya, Kanchanwadi, Paithan road, Chh.Sambhajinagar, 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9373398347 |
| Fax |
|
| Email |
nikhilrandave1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita Fadnavis |
| Designation |
Professor |
| Affiliation |
CSMSS Ayurveda Mahavidyalaya and Rugnalaya 431002 Chh. Sambhajinagar |
| Address |
OPD No. 14 Kaumarbhritya department, C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya, Kanchanwadi, Paithan road, Chh.Sambhajinagar, 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9172933561 |
| Fax |
|
| Email |
dr.kavitafadnavis@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavita Fadnavis |
| Designation |
Professor |
| Affiliation |
CSMSS Ayurveda Mahavidyalaya and Rugnalaya 431002 Chh. Sambhajinagar |
| Address |
OPD No. 14 Kaumarbhritya department, C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya, Kanchanwadi, Paithan road, Chh.Sambhajinagar, 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9172933561 |
| Fax |
|
| Email |
dr.kavitafadnavis@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD No. 14 Kaumarbhritya department, C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya, Kanchanwadi, Paithan road, Chh.Sambhajinagar, 431011 |
|
|
Primary Sponsor
|
| Name |
Dr Nikhil Vishnu Randave |
| Address |
OPD No. 14 Kaumarbhritya department, C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya, Kanchanwadi, Paithan road, Chh.Sambhajinagar, 431011 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| CSMSS Ayurveda Mahavidyalaya and Rugnalaya Chh Sambhajinagar |
OPD No. 14 Kaumarbhritya department, C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya, Kanchanwadi, Paithan road, Chh.Sambhajinagar, 431011 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nikhil Vishnu Randave |
CSMSS Ayurved Mahavidyalaya and Rugnalaya, Chh sambhajinagar |
OPD No. 14 Kaumarbhritya department, C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya, Kanchanwadi, Paithan road, Chh.Sambhajinagar, 431011
Aurangabad
MAHARASHTRA |
9373398347
nikhilrandave1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya, Aurangabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J00||Acute nasopharyngitis [common cold]. Ayurveda Condition: PRATISYAYAH/PINASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shrungyadi Churna, Reference: Charaka Samhita. Translated by Vaidya Bhagwan Dash. 1st ed. Varanasi: Chaukhamba Sanskrit Sansthan; 2012., Route: Oral, Dosage Form: Churna/ Powder, Dose: 1000(mg), Frequency: tds, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Koshna Jala ), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shatyadi churna, Reference: Yogaratnakar Ut/Nasarogadhikar 7/72, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1000(mg), Frequency: tds, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1. Children between age of 5 to 15 years.
2. The selection of the patient will be irrespective of their sex, religion, socioeconomic status.
3. Patients with sign and symptoms of Pratishaya which are mentioned in subjective criteria.
4. Parents of children willing to give written consent.
|
|
| ExclusionCriteria |
| Details |
1. Children with congenital or structural abnormalities of the nasal cavity, such as Deviated Nasal Septum or Nasal polyps.
2.Patients exhibiting clinical features of lower respiratory tract infections, including bronchial asthma, pneumonia, emphysema, bronchiectasis, pleurisy, lung abscess, or pleural effusion.
3.Children diagnosed with systemic conditions like tuberculosis, HIV, hepatitis B, or those who are immunocompromised or affected by other debilitating diseases.
4. Children who need any surgical procedure
|
|
|
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 |
| Reduction in the severity of symptoms of Pratishyaya in children after treatment with Shrungyadi Churna |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
30/03/2026 |
| 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
|
The study focuses on Pratishyaya, a common disorder of the Pranavaha Strotas described in Ayurvedic texts. Pratishyaya refers to continuous nasal discharge and is mainly associated with Vata and Kapha dosha imbalance. It is commonly seen in children. In modern terms, Pratishyaya is correlated with rhinitis, which is inflammation of the nasal mucosa characterized by nasal discharge, sneezing, and nasal congestion. The condition is highly prevalent in children and affects their daily activities and quality of life. This study aims to evaluate the efficacy of Shrungyadi Churna in the management of Pratishyaya in children through a randomized controlled clinical trial. Rhinitis is one of the most common respiratory disorders in children, with a prevalence of about 15 to 30 percent in India. Children are more susceptible due to their developing immune system. Many cases are treated only symptomatically, which may lead to recurrence and chronicity. From an Ayurvedic perspective, Pratishyaya in children is mainly associated with Kapha imbalance along with Vata and Ama. Early and appropriate management is important in pediatric age. Shrungyadi Churna is a classical Ayurvedic formulation indicated in respiratory disorders and Pratishyaya. Therefore, this study is undertaken to evaluate its effectiveness in children and to provide age appropriate, safe, and effective management. |