| CTRI Number |
CTRI/2025/09/094335 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study on patients with Allergic Rhinitis(Vataja Pratishyaya) to evaluate the effect of two herbal decoctions (Shirishadi Kwath and Gojihwadi Kwath) given orally along with Ayurvedic nasal drops (Vidaryadi Ghrita Nasya) |
|
Scientific Title of Study
|
Comparative clinical evaluation of Shirishadi Kwath and Gojihwadi Kwath orally along with Vidaryadi Ghrita Nasya in Vataja 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 |
Shivani Sharma |
| Designation |
PG Scholar |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD-3, Department of Shalakya Tantra, Patanjali Ayurveda Hospital, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8219852066 |
| Fax |
|
| Email |
shivanisharma1063@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Kumar Pandey |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD-3, Department of Shalakya Tantra, Patanjali Ayurveda Hospital, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8859761559 |
| Fax |
|
| Email |
arunpandey.pandey@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shivani Sharma |
| Designation |
PG Scholar |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD-3, Department of Shalakya Tantra, Patanjali Ayurveda Hospital, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8219852066 |
| Fax |
|
| Email |
shivanisharma1063@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar, Uttarakhand, India, 249405
|
|
|
Primary Sponsor
|
| Name |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar, Uttarakhand, India, 249405 |
| 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 Shivani Sharma |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar |
OPD-3, Department of Shalakya Tantra, Patanjali Ayurveda Hospital, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar
Hardwar
UTTARANCHAL |
8219852066
shivanisharma1063@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J309||Allergic rhinitis, unspecified. Ayurveda Condition: VATAJAPRATISYAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Shirishadi Kwath, Reference: NA, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Gojihwadi Kwath, Reference: Siddhayoga Samgraha, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with classical signs & symptoms of Vataja Pratishyaya [Allergic Rhinitis] described as per ayurvedic and modern science
2. Patients between the age group of 10 years to 60 years.
3. Patients in related group who are fit for Nasya Karma / Nasya yogya vyakti.
4. Patient willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Patients less than 10 years and above 60 years of age.
2. Patients who are contraindicated for Nasya Karma.
3. Patients with chronic infective respiratory diseases, other conditions like sinusitis, chronic rhinosinusitis, DNS requiring surgical intervention, nasal polyp, tumors etc.
4. Patient suffering from any systemic diseases like uncontrolled diabetes mellitus, uncontrolled hypertension, heart disease, cancer and receiving medication which may alter the results of study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment will be done on the basis of subjective parameters.
Subjective Parameters
1) Nasaavrodha (Nasal obstruction)
2) Nasa Srava (Rhinorrhea)
3) Kshavathu (Sneezing)
4) Shirashool (Headache)
5) Galataluoshtha Shosha (Dryness of throat)
6) Swarabheda (Change of Voice) |
Baseline (before treatment); End of treatment (4 weeks, primary time point) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment will be done on the basis of objective parameters.
OBJECTIVE PARAMETERS
1) Spatula Test
2) Absolute Eosinophils Count |
Baseline (before treatment); End of treatment (4 weeks). |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
16/09/2025 |
| Date of Study Completion (India) |
22/05/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Understanding Allergic Rhinitis through Ayurvedic Principles of Vataja Pratishyaya, published in International Research Journal of Ayurveda and Yoga, Volume 9, Issue 2. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This comparative clinical study evaluated the efficacy of Shirishadi Kwath and Gojihwadi Kwath administered orally along with Vidaryadi Ghrita Nasya in patients with Vataja Pratishyaya (Allergic Rhinitis). The study was conducted on 60 patients attending the OPD/IPD of the Shalakya Tantra Department, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar. The patients were randomly allocated into two groups of 30 each. Both groups received Vidaryadi Ghrita Nasya for 7 days as a common intervention. In addition, Group A received Shirishadi Kwath orally for 30 days, while Group B received Gojihwadi Kwath orally for 30 days. Assessment was carried out before and after treatment based on subjective and objective parameters, with follow-up at 1 month after completion of treatment. The study was completed as per the approved protocol. |