| CTRI Number |
CTRI/2026/01/100081 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
31/12/2025 |
| 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
|
To Evaluate the Efficacy of Gud-Aadrakam in the patients of Vataja Pratishyaya (Allergic Rhinitis) |
|
Scientific Title of Study
|
An Open Label Randomized Controlled Clinical Study to Evaluate the Efficacy of Gud-Aadrakam in the management of Vataja Pratishyaya w.s.r. to 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 Vijayant Bhardwaj |
| Designation |
HOD Professor PG Department of Shalakya Tantra |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital, Paprola |
| Address |
PG Department of Shalakya Tantra, Rajiv Gandhi Govt Post
Graduate Ayurvedic College and Hospital, Paprola, Distt. Kangra,
H.P. 176115, India
Kangra
HIMACHAL PRADESH
176115
India
Phone 941801756
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
941801756 |
| Fax |
|
| Email |
bhardwajvijayant@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayant Bhardwaj |
| Designation |
HOD Professor PG Department of Shalakya Tantra |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital, Paprola |
| Address |
PG Department of Shalakya Tantra, Rajiv Gandhi Govt Post
Graduate Ayurvedic College and Hospital, Paprola, Distt. Kangra,
H.P. 176115, India
Kangra
HIMACHAL PRADESH
176115
India
Phone 941801756
HIMACHAL PRADESH
176115
India |
| Phone |
941801756 |
| Fax |
|
| Email |
bhardwajvijayant@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shailja Thakur |
| Designation |
PG Scholar |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital, Paprola |
| Address |
PG Department of Shalakya Tantra,Rajiv Gandhi Govt Post
Graduate Ayurvedic College and Hospital, Paprola, Distt. Kangra,
H.P. 176115, India
Kangra
HIMACHAL PRADESH
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7018681826 |
| Fax |
|
| Email |
thakurshailza493@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Pharmacy Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital, Paprola,
Kangra, H.P. |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital, Paprola |
| Address |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital,
Paprola, Distt. Kangra, H.P. 176115, India
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vijayant Bhardwaj |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital, Paprola |
OPD No. 201, Rajiv
Gandhi Govt Post
Graduate Ayurvedic
College and Hospital,
Paprola, Distt. Kangra,
H.P. 176115, India
Kangra
HIMACHAL PRADESH
Kangra
HIMACHAL PRADESH |
9418017568
bhardwajvijayant@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(Human) Rajiv Gandhi Govt. Post Graduate Ayurvedic College and Hospital, Paprola, Distt. Kangra, H.P. 176115 India |
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 | Classical | | (1) Medicine Name: Gud-Aadrakam , Reference: Abhinav Chintamani , Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Fexofinadine HCl | Adult Dose - 120 mgs OD with water
Route of administration - Oral
Duration- 15 days
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling the diagnostic criteria based on signs and symptoms of Vataja Pratishyaya (Allergic Rhinitis) in Ayurveda classics and modern science.
Patient willing to participate.
Patient of either gender in the age group above 18 years.
|
|
| ExclusionCriteria |
| Details |
Patient not willing for the trial.
Patients requires surgical treatment e.g. cases of nasal polyp.
Patients with history of multiple episodes of epistaxis.
Patients below age of 18 years.
Patient suffering from diseases like Diabetes mellitus, Carcinoma, Tuberculosis.
Pregnant and lactating women.
Hypertrophic rhinitis
Atrophic rhinitis
Rhinitis sicca.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief in sign and symptoms of allergic rhinitis in patient.
|
15 Days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study effect of Gud-Aadrakam oral administration in improvement of Vataja Pratishyaya.
|
15 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
I would like to publish my research work after completion of the trial as soon as possible. Patients
will be selected from OPD/IPD of RGGPG Ayurvedic College and Hospital,Paprola. 2 groups of 30
patients will be registered and assessed to evaluate the effect of Gud-Aadrakam oral administration in the management of Vataja Pratishyaya w.s.r. to Allergic Rhinitis. |