| CTRI Number |
CTRI/2026/04/107751 [Registered on: 07/04/2026] Trial Registered Prospectively |
| Last Modified On: |
06/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Study of efficacy a tamarind leaf extract Syrup and Levocetirizine Syrup in the Management of Common Cold in Children Between 2 and 12 Years of Age.” |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED CLINICAL TRIAL TO COMPARE THE EFFECTIVENESS OF ORAL
ADMINISTRATION OF CHINCHA PATRA SYRUP WITH LEVOCETIRIZINE SYRUP IN MANAGEMENT OF
PRATISHYAYA IN CHILDREN (2 To 12 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 Onkar Rajkumar Parbat |
| Designation |
PG SCHOLAR |
| Affiliation |
Tilak ayurveda mahavidyalaya pune |
| Address |
Department of kumarbhritya Tilak ayurveda Mahavidyalaya rasta peth pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9172051587 |
| Fax |
|
| Email |
parbatonkar45@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRGAJANAN ANKUSH CHEKE |
| Designation |
professor kumarbhritya department |
| Affiliation |
Tilak Ayurved Mahavidyalaya,Kaumarbhritya department |
| Address |
Tilak Ayurved Mahavidyalaya,1st floor, Kaumarbhritya department,
Rastapeth, 583/2, Pune.Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
8087790907 |
| Fax |
|
| Email |
drgajanancheke@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR GAJANAN ANKUSH CHEKE |
| Designation |
Professor of kumarbhritya department |
| Affiliation |
Tilak Ayurved Mahavidyalaya,pune |
| Address |
Tilak Ayurved Mahavidyalaya,1st floor, Kaumarbhritya department,
Rastapeth, 583/2, Pune.Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
8087790907 |
| Fax |
|
| Email |
drgajanancheke@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth Tarachand Ramnath Charitable Ayurvedic Hospital, 580/2 Rasta Peth, Pune 411011 Maharashtra,India |
|
|
Primary Sponsor
|
| Name |
TILAK AYURVEDA MAHAVIDYALAYA |
| Address |
Tilak Ayurved Mahavidyalaya, 1st floor, Kaumarbhritya department,
Rastapeth, 583/2, Pune. Pune |
| 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 Onkar Rajkumar Parbat |
Seth Tarachand Ramnath Ayurvedic Hospital Pune |
Tilak Ayurved Mahavidyalaya, 1st floor, Kaumarbhritya department,
Rastapeth, 583/2, Pune.
Pune
MAHARASHTRA |
09172051587
parbatonkar45@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committe TAMV PUNE |
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 | Comparator Arm (Non Ayurveda) | Drug | Classical | | (1) Medicine Name: Levocetirizine syrup, Reference: K.D Tripathi essential of medical pharmacology 8th edition , Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 2.5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | Drug | - | | | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chincha patra syrup , Reference: Bhaiasajya Ratnavali, chikitsa sthan,nasaroga,chapter 63, verses 20, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 0.66(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: -
|
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children between the age group of 2 to 12 years.
2.Participants with Nava pratishyaya irrespective of gender, religion, socio-economic status.
3.Participants suffering Pratishyaya with having at least 3 classical symptoms of the following.
a) Kshavathu (Sneezing) b) Nasavarodh (Nasal congestion) c) Shirashoola (Headache)
d) Nasakandu (Itching in nose) e) Tanustrava (Rhinorrhea)
4. Participants with Complaint of headache above 5 years of age. |
|
| ExclusionCriteria |
| Details |
1. Participants with symptoms of chronic rhinitis ,sinusitis.
2.Known case of deviated nasal septum, nasal polyps, nasal malignancy, systemic diseases.
3. Known case of Asthma and chronic infections like Tuberculosis, Chronic obstructive pulmonary disease,etc.
4. Known case of Congenital anomalies related to respiratory system. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in Symptoms of common cold ,headache |
3 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in all symptoms of common cold |
5 day |
|
|
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)
|
20/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/04/2026 |
| 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 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 - YES
- What data in particular will be shared?
Response (Others) -
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [parbatonkar45@gmail.com].
- For how long will this data be available start date provided 03-03-2026 and end date provided 15-11-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The study will be intervened by the treatment of Chincha Patra Syrup and Levocetirizine Syrup to group A and group B respectively. The efficacy of the therapy will be assessed on the basis of subjective criteria for statistical analysis. Scoring will be designed according to the severity of symptoms. The subjective gradation of symptoms will be done as follows and the intensity of each symptom will be calculated before treatment, after treatment and after follow up. The effect of treatment result will be assessed in regards to clinical signs and symptoms on the basis of grading and scoring system. The signs and symptoms will be assessed by adopting the suitable scoring method. |