| CTRI Number |
CTRI/2024/08/072613 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
20/07/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurveda intervention in Allergic rhinitis |
|
Scientific Title of Study
|
A randomised controlled parallel study to compare the efficacy of Haridrakhanda to combination of Haridrakhanda and Anutailanasya in 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 Krishna Rao S |
| Designation |
Research Officer |
| Affiliation |
Central Ayurveda Research Institute,Bhubaneswar |
| Address |
Opd Department,Room no 1, Ground floor
Central Ayurveda Reserach Instite,
Bharatpur ,Near Kalinga Studio Chowk,
Khordha
ORISSA
751003
India |
| Phone |
9037690951 |
| Fax |
|
| Email |
krdrkrishnarao@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gurucharan Bhuyan |
| Designation |
Assistant Director |
| Affiliation |
Central Ayurveda Research Institute,Bhubaneswar |
| Address |
Central Ayurveda Research Institute, Bharatpur, Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
9037690951 |
| Fax |
|
| Email |
drbhuyangc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR KRISHNA RAO S |
| Designation |
Research Officer |
| Affiliation |
Central Ayurveda Research Institute,Bhubaneswar |
| Address |
Opd Department, Room no 1,Ground floor,
Central Ayurveda Research Institute, Bharatpur, Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
9037690951 |
| Fax |
|
| Email |
krdrkrishnarao@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Ayurveda Research Institute,Bharapur,Bhubaneswar,Odisha 751003.India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NA |
| Type of Sponsor |
Other [PHD STUDY] |
|
|
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 |
| DrKrishna Rao S |
Central Ayurveda Research InstituteBhubaneswar |
Opd Department,Room no 1,Groud floor,
Central Ayurveda Reserach Institute,Bharatpur,Bhubaneswar
Khordha
ORISSA |
9037690951
krdrkrishnarao@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC CCRAS-CARI,BHUBANESWAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J309||Allergic rhinitis, unspecified. Ayurveda Condition: SITAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: HARIDRA KHANDA AND ANUTHAILA, Reference: API, Route: Oral, Dosage Form: Khanda /Granules, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: LUKEWARM WATER), Additional Information: WITH ANU THAILA - 2 DROPS IN NOSTRIL IN MORNING | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: HRAIDRA KHANDA ONLY, Reference: API, Route: Oral, Dosage Form: Khanda /Granules, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age group of 18 to 60 years at the time of enrolment, irrespective of gender.
Clinical symptoms for at least 1 month or more.
Presence of two or more nasal symptoms: watery rhinorrhoea, nasal obstruction, sneezing, and nasal itching.
Total Nasal Symptom Score (TNSS) of 6 or more (0 no symptoms, 1 mild symptoms, 2 moderate symptoms, 3 severe symptoms).
Willing to give written, informed consent to participate in this study and come for follow-ups as advised. |
|
| ExclusionCriteria |
| Details |
Patients with deviated nasal septum/ nasal polyps/ nasal growth/ adenoids/ asthma.
Patients with impaired liver and kidney functions, anaemia, and unstable cardiovascular conditions or cerebrovascular conditions.
Currently or previously treated for any malignancy.
Patients on steroid therapy.
Pregnant or lactating mothers. .
Those who have any history of drug allergy to any of the investigational products.
Illiterate patients without a literate relative/guardian who can explain the procedures and maintain the patient diary,
• Patients suffering from chronic debilitating diseases like Uncontrolled DM, JDM, HIV, HBsAg,
Non-consenting individuals
Any other patients who are considered unsuitable for recruitment by the investigator
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nasal symptoms (watery rhinorrhea, sneezing, nasal obstruction, nasal itching) measured using the Total Nasal Symptom Score (TNSS) of allergic rhinitis patients at baseline and the end of intervention |
Total Nasal Symptom at baseline,28th and 56th day.
IgE and AEC at Baseline and 28th day.Score |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Change in Serum Immunoglobulin E level
2.Change in Absolute Eosnophil Count (AEC)
3.Physico-chemical parameters,TLC and HpTLC of Anu taila |
Baseline and 28th day |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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 |
|
Date of First Enrollment (India)
|
26/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
26/08/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
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 - NO
|
Brief Summary
Modification(s)
|
This randomized controlled parallel study aims to evaluate the efficacy of Haridrakhanda alone compared to a combination of Haridrakhanda and Anutaila Nasya in managing allergic rhinitis (AR). AR, a Type 1 IgE-mediated hypersensitivity disorder, significantly impacts the quality of life by causing symptoms like sneezing, rhinorrhea, nasal congestion, and itching. Conventional treatments often fail to fully control these symptoms, leading patients to seek alternative therapies like Ayurveda. Haridrakhanda, an Ayurvedic formulation with anti-allergic and immune-boosting properties, is widely used for AR. Nasya (nasal administration) with Anutaila, a classical Ayurvedic oil, is another traditional treatment for head and neck diseases, including AR. The study will assess the effectiveness of these treatments by measuring the Total Nasal Symptom Score (TNSS), serum IgE, and absolute eosinophil count (AEC) over four weeks. The trial involves 144 participants, aged 18–60, who will be randomly assigned to two groups: one receiving only Haridrakhanda and the other receiving both Haridrakhanda and Anutaila Nasya. The study aims to determine whether the combination therapy is more effective than Haridrakhanda alone in reducing the severity of nasal symptoms and IgE/AEC levels. The trial will also include an analysis of the physicochemical properties of Anutaila. Outcomes will be assessed at baseline, 28 days, and 56 days post-treatment. |