| CTRI Number |
CTRI/2024/07/070747 [Registered on: 16/07/2024] Trial Registered Prospectively |
| Last Modified On: |
01/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Combined effect of sunthyady ghritha nasal drops and vyoshadi vataka internally with honey in reducing signs and symptoms of allergic rhinitis |
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Scientific Title of Study
|
Combined effect of sunthyadi ghritha prathimarsha nasya and vyoshadi vataka internally with honey 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 |
Anoopa P P |
| Designation |
Pg scholar |
| Affiliation |
Government ayurveda college kannur pariyaram |
| Address |
Department of shalakyatantra secondnd floor A block Government ayurveda college kannur pariyaram
PIN 670503
Kannur KERALA 670503 India |
| Phone |
8281475923 |
| Fax |
|
| Email |
anoopapp101@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ambili K |
| Designation |
Associate professor department of shalakyatantra |
| Affiliation |
Government ayurveda college kannur pariyaram |
| Address |
Room number 8 Department of shalakyatantra Government ayurveda college kannur pariyaram
PIN 670503
Kannur KERALA 670503 India |
| Phone |
9446028794 |
| Fax |
|
| Email |
amlikavinal@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Anoopa P P |
| Designation |
Pg scholar |
| Affiliation |
Government ayurveda college kannur pariyaram |
| Address |
Room number 8 Department of shalakyatantra Government ayurveda college kannur pariyaram PIN 670503
Kannur KERALA 670503 India |
| Phone |
8281475923 |
| Fax |
|
| Email |
anoopapp101@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government ayurveda college kannur pariyaram op no 8 department of shalakyatantra pin 670503 |
|
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Primary Sponsor
|
| Name |
Anoopa P P |
| Address |
Government ayurveda college kannur pariyaram
PIN 670503 |
| Type of Sponsor |
Other [self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR Anoopa P P |
Government ayurveda college kannur pariyaram |
Government ayurveda college kannur pariyaram op no 8 department of shalakyatantra Ground floor pin 670503 Kannur KERALA |
8281475923
anoopapp101@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee government ayurveda college kannur pariyaram |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J309||Allergic rhinitis, unspecified. Ayurveda Condition: KSHAVATHUH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | pratimarSaH, पà¥à¤°à¤¤à¤¿à¤®à¤°à¥à¤¶ | (Procedure Reference: Ashtangahridaya, Procedure details: Procedure Reference: ASHTANGAHRIDHAYAM, Procedure details: Participants will be given with sunthyadi ghritha in dropper bottle for nasal administration. Methods of administration will be explained & demonstrated to the participant on the first day. The research participant is made to lie straight on his back with slight lowering of head, extending arms and legs. The ghritha is made luke warm. Taken in sterile dropper bottle and will be instilled 0.5ml in to each nostril, keeping the other one closed Inhale the ghritha and spit if it reaches the throat )
(1) Medicine Name: SUNTHYADI GHRITHA, Reference: CHAKRADATTA, Route: Nasal, Dosage Form: Ghrita, Dose: 0.5(ml), Frequency: od, Duration: 21 Days) (1) Medicine Name: Sunthyadi ghritha, Reference: Chakradatta, Route: Nasal, Dosage Form: Ghrita, Dose: 0.5(ml), Frequency: od, Duration: 21 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vyoshadi vataka, Reference: Ashtangahridaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -Honey), Additional Information: - |
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Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with allergic rhinitis
Patients of age group 15-45 years
Participants who are willing to give written informed consent and assent
|
|
| ExclusionCriteria |
| Details |
Participants with existing nasal polyp tumors DNS severe dyspnea and sinusitis
Known cases of bronchial asthma cardiovascular diseases diabetic mellitus carcinoma AIDS
Known cases of bleeding disorders
Infective nasal disorders persisting even after 6 month
Participants who are already undergoing treatment for any allergic diseases
Pregnant and lactating women
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Method of Generating Random Sequence
|
Other |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total Nasal Symptom Score (TNSS) |
37 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
AEC(Absolute Eosinophil Count)
Serum IgE |
37 DAYS |
|
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Target Sample Size
|
Total Sample Size="35" Sample Size from India="35"
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 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Allergic rhinitis is an IgE mediated immunologic response of nasal mucosa to airborne allergens and is characterized by watery nasal discharge, nasal obstruction, sneezing and itching in the nose. Repeated attack and improper management of the disease lead to many complications like eczema, nasal polyps, otitis media, asthma, conjunctivitis, sinusitis, migraine etc. Living with chronic allergies can lead to reduced quality of life and may affect one’s daily activities. Currently, the global prevalence of allergic rhinitis is approximately 10% to 30% in adults and 40% in children. Approximately 22% of adolescents currently suffer from allergic rhinitis in India. In Modern medical system, a wide range of intranasal corticosteroids, antihistamines, leukotriene receptor and decongestants are available. But these drugs give only symptomatic relief and also are not devoid of adverse effects. So we need such a treatment modality which has maximum effect and having no complications. The clinical features of Allergic rhinitis shows similarity with Kshavathu, which is mentioned as a nasaroga in Ayurveda classics. Sunthyadi ghritha nasya is mentioned in Chakradatta in the context of Nasarogadhikara. It includes sundi, kana, kushta, bilva and draksha. Vyoshadi vataka is an ayurvedic classical formulation mentioned in nasaroga pratisheda in ashtanga hridaya uttarasthana. Hence this study is designed to find out the combined effect of sunthyadi ghritha prathimarsha nasya and vyoshadi vataka with honey internally in the management of allergic rhinitis. Aim of the study is to assess the combined effect of ayurvedic management through prathimarsha nasya with sunthyadi ghritha and vyoshadi vataka with honey internally in allergic rhinitis. This study will be conducted as a pre and post interventional study in op setting of Government Ayurveda College Kannur. The study population will be selected on the basis of inclusion and exclusion criteria. Participant will be given sunthyadi ghritha prathimarsha nasya (0.5ml) and vyoshadi vataka 6gm twice daily internally with honey for duration 21 days. The follow up will be on 37th day. Assessment will be done using grading of Total Nasal Symptom Score, absolute eosinophil count(AEC), immunoglobulin E (IgE). Result will be statically analysed by paired t test and wilcoxon signed rank test.
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