| CTRI Number |
CTRI/2024/07/070306 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
15/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Nasal spray in sinusitis and cold |
|
Scientific Title of Study
|
To study the efficacy of Kalingadi Arka nasal spray in Kaphaja prathishyaya( Chronic rhinosinusitis) An open labelled randomized controlled clinical study |
| 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 Vidya R E |
| Designation |
Post graduate Resident |
| Affiliation |
SDM institute of Ayurveda and Hospital |
| Address |
Room no-16, Department of Shalakya tantra, SDM institute of Ayurveda, Anchepalya, Bengaluru, Karnataka
Bangalore
KARNATAKA
560074
India |
| Phone |
76191659348 |
| Fax |
|
| Email |
vidyakumbar27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamatha K V |
| Designation |
Professor and Head of the department |
| Affiliation |
SDM institute of Ayurveda and Hospital |
| Address |
room no 16, Department of shalakya tantra, SDM institute of Ayurveda, Anchepalya, Bengaluru, karnataka
SDM institute of Ayurveda, Anchepalya, Bengaluru, Karnataka
Bangalore
KARNATAKA
560074
India |
| Phone |
76191659348 |
| Fax |
|
| Email |
mail2mamatha@sdmayurbangalore.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mamatha K V |
| Designation |
Professor and Head of the department |
| Affiliation |
SDM institute of Ayurveda and Hospital |
| Address |
room no 16, Department of shalakya tantra, SDM institute of Ayurveda, Anchepalya, Bengaluru, karnataka
SDM institute of Ayurveda, Anchepalya, Bengaluru, Karnataka
Bangalore
KARNATAKA
560074
India |
| Phone |
76191659348 |
| Fax |
|
| Email |
mail2mamatha@sdmayurbangalore.in |
|
|
Source of Monetary or Material Support
|
| SDM institute of Ayurveda and hospital, Anchepalya, Bengaluru,560074 |
|
|
Primary Sponsor
|
| Name |
Dr VIDYA R E |
| Address |
SDM institute of Ayurveda and hospital, Anchepalya, Bengaluru, Karnataka-560074 |
| Type of Sponsor |
Other [Self] |
|
|
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 Mamatha K V |
SDM institute of Ayurveda and Hospital |
Room no-16, Department of Shalakya tantra, SDM institute of Ayurveda and Hospital, Anchepalya, Bengaluru, Karnataka-560074
Bangalore
KARNATAKA |
9845393236
mail2mamatha@sdmayurbangalore.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Dharmasthala manjunatheshwara institute of Ayurveda and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J310||Chronic rhinitis. Ayurveda Condition: PRATISYAYAH/PINASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kalingadi Arka Nasal spray , Reference: Yogarathnakara Nasarogachikitsa adhyaya, verse no 43, Route: Nasal, Dosage Form: Arka, Dose: 0.05(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kalingadi taila, Reference: Chakradatta, Nasarogadhikara 58/8, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with clinical features of Kaphaja Prathishyaya (chronic rhinosinusitis)
2.Subjects fit for Nasya karma
3.Patient of either sex, with age group between 20-40 years
4.Patients with chronicity less than 5year
|
|
| ExclusionCriteria |
| Details |
1. Patients with any other systemic disorders (like TB, HIV, Retro positive diabetes, Hypertension and Thyroid.) that may interfere the course of treatment
2. Any associated conditions like migraine headache, referred pain from dental pathology will be excluded
3. Patients with nasal polyps along with rhinosinusitis will not be considered for the study
4. Patients suffering from Chronic Simple Rhinitis associated with tonsillitis, adenoids
5. Patients of gross DNS being the reason for nasal blockage
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Nasa srava (Nasal discharge)
2.Pratisthabdam (Nasal obstruction)
3.Gala, Oshta, Talu kanduyana (Itching throat, palate and lips)
4.Mukhashiro guruthva (Heaviness of Face and Head)
5.Aruchi (Anorexia)
6.Nasanaha (Oedema of the middle meatus)
7.Shirashoola (Headache)
|
15 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Sustained effect of treatment on Subjective Parameters
2.Improvement changes in SNOT-22 questionnaire.
3.To develop easily approachable cost-effective treatment
|
15 DAYS |
1.Sustained effect of treatment on Subjective Parameters
2.Improvement changes in SNOT-22 questionnaire.
3.To develop easily approachable cost-effective treatment
|
15 DAYS |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
19/07/2024 |
| 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="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Patients of Chronic rhinosinusitis tend to use nasal spray more often due to its simple convenient and easily applicable nasal delivery system. Thus, as per the practicality and quest for such treatment modalities in Ayurveda. Arka is adopted in the form of nasal spray which is prepared by combination of Jala and Agni which makes the medicaments laghupaki, vyavayi, vikasi and thus assimilating quickly in the body, in the present study the drugs of Kalingadi avapeeda nasya will be formulated to Arka as a new ideology and will be administered to patients in the form of nasal spray which will be economical and beneficial
|