| CTRI Number |
CTRI/2024/05/067447 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
14/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Study to Examine the Effects of Two Ayurvedic Formulations in the Treatment of Hay Fever: Allergy Rakshak Avaleha Alone and Allergy Rakshak Avaleha Combined with Allergy Rakshak Ghee |
|
Scientific Title of Study
|
Effectiveness of Allergy Rakshak Avaleha alone and combination with Allergy Rakshak Ghee in managing allergic rhinitis: An open label randomized controlled study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Avaleha2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Varun |
| Designation |
Manager |
| Affiliation |
Arogyam Ayurvedic Allergy Hospital, Jalandhar, Punjab |
| Address |
Ayurveda Clinic, Room No. 2, Arogyam Ayurvedic Allergy Hospital
Jalandhar
PUNJAB
144003
India |
| Phone |
9878235154 |
| Fax |
|
| Email |
manager.arogyam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varun |
| Designation |
Manager |
| Affiliation |
Arogyam Ayurvedic Allergy Hospital, Jalandhar, Punjab |
| Address |
Ayurveda Clinic, Room No. 2, Arogyam Ayurvedic Allergy Hospital
Jalandhar
PUNJAB
144003
India |
| Phone |
9878235154 |
| Fax |
|
| Email |
manager.arogyam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varun |
| Designation |
Manager |
| Affiliation |
Arogyam Ayurvedic Allergy Hospital, Jalandhar, Punjab |
| Address |
Ayurveda Clinic, Room No. 2, Arogyam Ayurvedic Allergy Hospital
Jalandhar
PUNJAB
144003
India |
| Phone |
9878235154 |
| Fax |
|
| Email |
manager.arogyam@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Arogyam Ayurvedic Allergy Hospital |
| Address |
7R, Mall Rd, opposite Thind Eye Hospital, Model Town, Jalandhar,144003, Punjab, India |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Harveen |
Arogyam Ayurvedic Allergy Hospital |
Ayurveda Clinic, Room No. 2, 7R, Mall Rd, Model Town
Jalandhar
PUNJAB |
9878235154
drharveen2099@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Lovely Professional University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J309||Allergic rhinitis, unspecified. Ayurveda Condition: PRATISYAYAH/PINASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Allergy Rakshak Avaleha, Reference: NA, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 20(g), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Allergy Rakshak Ghee, Reference: NA, Route: Topical, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 2(drops), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: Allergy Rakshak Ghee to be taken in combination with Allergy Rakshak Avaleha | | 3 | Comparator Arm (Non Ayurveda) | | - | Levocetirizine and Montelukast | Combination of levocetirizine (5 mg) and montelukast (10 mg) orally once daily for 28 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Allergic rhinitis patients of both genders, aged between 18 and 65 years at the time of enrollment
Presence of 2 or more nasal symptoms (sneezing, watery rhinorrhea, nasal congestion, and nasal itching)
Total Nasal Symptom Score (TNSS) greater or equal to 2 (TNSS is calculated by adding scores for each nasal symptom on a four-point scale (0 means no symptoms, 1 means mild symptoms, 2 means moderate symptoms, 3 means severe symptoms), with a maximum TNSS of 12) |
|
| ExclusionCriteria |
| Details |
Patients with deviated nasal septum, nasal polyps, or any clinically significant nasal anomaly
Presence of upper respiratory tract infections or severe asthma, impaired hepatic and renal functions, abnormal cardiovascular or cerebrovascular conditions, or anemia, or a history of known systemic disorders
Currently or previously treated for malignancy
Undergoing steroid therapy
Already receiving medications for allergic rhinitis or receiving antihistamines
Known allergies to investigational products or their ingredients
Pregnant or lactating mothers
Any other individuals deemed unsuitable for inclusion by the investigators |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Total Nasal Symptom Score (TNSS), serum IgE levels, and eosinophil count |
TNSS: 28 days and after 1 month of follow up; Serum IgE levels and eosinophil count: 28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Health-related quality of life (HRQoL) |
28 days and after 1 month of follow up |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
25/05/2024 |
| 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="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
|
This open-label, randomized, parallel-group trial will be conducted at Arogyam Ayurvedic Allergy Hospital located in Jalandhar, Punjab, India. This aims to evaluate the effectiveness of Allergy Rakshak Avaleha alone and in combination with Allergy Rakshak Ghee for managing allergic rhinitis. Participants aged 18 to 65 with two or more nasal symptoms and a Total Nasal Symptom Score (TNSS) ≥ 2 will be enrolled. The primary objective is to assess the change in TNSS over a 28-day treatment period, while the secondary objective is to evaluate health-related quality of life (HRQoL). Participants will be divided into three groups: Group I will receive Allergy Rakshak Avaleha orally twice daily, Group II will receive Allergy Rakshak Avaleha orally twice daily along with topical Allergy Rakshak Ghee in each nostril, and Group III will receive standard therapy with levocetirizine and montelukast orally. By exploring alternative approaches to allergic rhinitis management, this study aims to potentially improve the quality of life of patients with allergic rhinitis.
|