| CTRI Number |
CTRI/2023/07/055051 [Registered on: 11/07/2023] Trial Registered Prospectively |
| Last Modified On: |
13/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An Ayurvedic Management of Allergic Rhinitis |
|
Scientific Title of Study
|
A Study To Evaluate The Effectiveness Of Lashunadi Avapidana Nasya And Shrungavera Swarasa Internally In The Management Of Kaphaja Prathishyaya W.R.T 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 Ravindrakumar |
| Designation |
Pg Scholar |
| Affiliation |
Government Ayurvedic Medical College Bangalore |
| Address |
Department Of Pg Studies In Shalakya Tantra ,Shalakya Tantra Opd, Room No.11, Government Ayurveda Medical College,Dhanvantari Road.
Bangalore
KARNATAKA
560009
India |
| Phone |
9740481313 |
| Fax |
|
| Email |
Monika.raj1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Syed Munawar Pasha |
| Designation |
Professor |
| Affiliation |
Government Ayurvedic Medical College Bangalore |
| Address |
Department Of Pg Studies In Shalakya Tantra , Shalakya Tantra Opd, Room No.11, Government Ayurveda Medical College, Dhanvantari Road,
Bangalore
KARNATAKA
560009
India |
| Phone |
9886593932 |
| Fax |
|
| Email |
smpasha78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravindrakumar |
| Designation |
Pg Scholar |
| Affiliation |
Government Ayurvedic Medical College Bangalore |
| Address |
Department Of Pg Studies In Shalakya Tantra Shalakya Tantra Opd, Room No.11, Government Ayurveda Medical College,Dhanvantari Road.
Bangalore
KARNATAKA
560009
India |
| Phone |
9886593932 |
| Fax |
|
| Email |
smpasha78@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Ravindrakumar
Sri Jayachamarajendra institute Of Indian Medicine Hospital, Government Ayurveda Medical College Campus Bangalore |
|
|
Primary Sponsor
|
| Name |
Dr Ravindrakumar |
| Address |
Department Of Pg Studies In Shalakya Tantra , Shalakya Tantra Opd, Room No.11, Government Ayurveda Medical College, Dhanvantari Road,
Bangalore, Karnataka |
| 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 Ravindrakumar |
Sri Jayachamarajendra Institute Of Indain Medicine Hospital |
Department Of Pg Studies In Shalakya Tantra ,Shalakya Tantra Opd, Room No.11, Government Ayurveda Medical College,Dhanvantari Road.
Bangalore
Bangalore
KARNATAKA |
9740481313
Monika.raj1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI JAYACHAMARAJENDRA INSTITUTE OF INDIAN MEDICINE HOSPITAL BANGALORE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J309||Allergic rhinitis, unspecified. Ayurveda Condition: KAPAJA-PRATISYAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Nasya | (Procedure Reference: Sharangadhara , Procedure details: After snehana & swedana to face 4 drops to each nostrils for 14 days)
(1) Medicine Name: Lashunadi Avapidana nasya, Reference: Caraka cikista 26/150-151, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 4(drops), Frequency: od, Duration: 14 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shrungavira swarasa with madhu, Reference: Sahasrayoga, Route: Oral, Dosage Form: Swaras/ Juice, Dose: 18(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Honey), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Irrespective of Gender, Occupation, Religion, Socio-Economic status
2) Subjects presenting with classical features of kaphoja prathishyaya.
3) Age group between 18-60 years. |
|
| ExclusionCriteria |
| Details |
1) Subjects contraindicated for Nasyakarma
2) Subjects suffering from other systemic and infectious disease like Uncontrolled Diabetes, HTN, TB, HIV shall be excluded
3) Subjects suffering with polyps, DNS requiring surgical intervention
4) Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Absolute Eosinophil Count
2) Erythrocyte Sedimentation. Rate |
58 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Nasal discharge
2) Itching in Nose, Eyes & Pharynx
3) Nasal obstruction
4) Heaviness of head
5) Sneezing
6) Cough
7) Oedema around eyelids |
58 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 |
|
Date of First Enrollment (India)
|
20/07/2023 |
| 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="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Prathishaya is one among the common diseases affecting respiratory system. Kaphaja prathishaya is characterised by snigdha Shukla kapha sruthi, Kandu in nasa thalu gala,shiro guruthva, shoonakshi, kasa
Based on above symptoms it can be compared with Allergic Rhinitis. It is a disorder of nose induced by an IgE mediated inflammation after Allergen exposure leading to Rhinorrhea, nasal pruritus, bilateral nasal stuffiness associated with cough,
In conventional medicinal system it is treated with antihistamines, nasal decongestants, corticosteroids, topical steroids which causes different side effects like drowsiness, thinitis medicamentosa, mucosal atrophy, several systemic disorders etc By considering these facts there is a need to develop a treatment which aims at reducing symptoms and improving immunity to overcome this condition
Nasya is a line of treatment for most of the urdhwa Jatru vikaras thus it is equally beneficial in treating kaphaja prathishyaya it is one among nasagata roga, and easily administrable in less duration of time.
In kaphaja prathishyaya, nasya with theekshna dravyas can give positive results hence Lashunadi Avapidana nasya is taken. It can improve nasal mucosa function by direct cleansing, removal of inflammatory mediators and enhancing mucociliary function. Shrungavira swarasa is taken with honey as anupana internal medication will boost the immunity as the drugs mentioned in this yoga is theekshna, ushna and rooksha which act as kapha hara
The drugs which are mentioned are cost effective, simple, easily available Considering above facts these treatment procedure expected to yield better results, hence the present study has been taken |