| CTRI Number |
CTRI/2026/01/102109 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
|
| 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 on comparing the effect of herbal drug formulations in common cold of school going children |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of Shirisharishta and Shirishavaleha in school going children with Pratishyaya (Allergic rhinitis) |
| 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 Nagre Pratik Subhash |
| Designation |
Post Graduate Scholar |
| Affiliation |
JSS Ayurveda Medical College |
| Address |
Department of PG Studies in Kaumarabhritya, JSS Ayurveda Medical College, No 41E, Lalithadripura Road,Alanahalli,Mysore
Mysore
KARNATAKA
570028
India |
| Phone |
7038656691 |
| Fax |
|
| Email |
pratik7nagre@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyothy K B |
| Designation |
Professor |
| Affiliation |
JSS Ayurveda Medical College |
| Address |
Department of PG Studies in Kaumarabhritya, JSS Ayurveda Medical College, No 41E, Lalithadripura Road,Alanahalli,Mysore
Mysore
KARNATAKA
570028
India |
| Phone |
7776014076 |
| Fax |
|
| Email |
jyothybmenon@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nagre Pratik Subhash |
| Designation |
Post Graduate Scholar |
| Affiliation |
JSS Ayurveda Medical College |
| Address |
Department of PG Studies in Kaumarabhritya, JSS Ayurveda Medical College, No 41E, Lalithadripura Road,Alanahalli,Mysore
Mysore
KARNATAKA
570028
India |
| Phone |
7038656691 |
| Fax |
|
| Email |
pratik7nagre@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS Ayurveda Medical College |
|
|
Primary Sponsor
|
| Name |
Dr Nagre Pratik Subhash |
| Address |
Department of PG Studies in Kaumarabhritya,JSS Ayurveda Medical College, No 41 E,Lalithadripura road , Alanahalli , Mysore |
| Type of Sponsor |
Other [SELF] |
|
|
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 Pratik Subhash Nagre |
JSS Ayurveda Medical College and Hospital |
OPD No 11, Department of Kaumarabhritya, JSS Ayurveda Medical College and Hospital, No 41E, Lalithadripura Road,Alanahalli,Mysore
Mysore
KARNATAKA |
7038656691
pratik7nagre@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Clearance Committee- Human JSS Ayurveda Medical College Mysuru |
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: Shirisha Arishta , Reference: Kaviraj Govind Das sen. Bhaisajyaratnavali with sidiprada commentary .edited by Mishra Siddhi Nadan .Reprint.Varanasi -Chaukhamba surbharati Prakashan ;2009.Chapter 31.Verse no.72-74.P-479., Route: Oral, Dosage Form: Arishta, Dose: 20(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Shrishavaleha, Reference: NA, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 11(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1.Children aged between 6 to 16 years will be selected irrespective of gender,religion & socioeconomic status.
2.Children fulfilling diagnostic criteria of Allergic rhinitis.
3.Children whose parents are willing to give informed assent. |
|
| ExclusionCriteria |
| Details |
1.Known cases of systemic disorder which may interfere with course of study
2.Known cases of any congenital anomalies which may interfere with course of study
3.Children who are on any other anti-allergic medications
4.Subjects with Nasal polyp, Epistaxis. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in severity of cardinal features of Pratishyaya as per TNSS , NOSE Scale and AEC levels |
0th day 3rd day 7th day 14th day 21st day 29th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in quality of life |
0th day 7th day 14th day 21st day 29th day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
27/04/2026 |
| 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="10"
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 proposed study is a randomized, open-label comparative clinical trial evaluating the efficacy of two Ayurvedic formulations—Shirisharishta and Shirishavaleha—in the management of Pratishyaya (allergic rhinitis) in school-going children aged 6–16 years. The study is being planned due to the high prevalence of Allergic Rhinitis in children and its impact on growth and quality of life, linking the condition with Ayurvedic concepts such as Vata-Kapha predominance and Gara Visha (Allergens). Shirisharishta and Shirishavaleha will be given to trial and comparator groups respectively consisting 20 subjects each for a period of 28 days in a pre decided dosage as per age. Assessment will be done based on the changes in the subjective parameters like TNSS Scale and Quality of life on 0th, 3rd, 7th, 14th, 21st and 29th day and Absolute Eosinophil counts before and after the trial. Statistical analysis of the data will be done post trial from which conclusion of the study will be drawn. |