| CTRI Number |
CTRI/2025/04/085696 [Registered on: 25/04/2025] Trial Registered Prospectively |
| Last Modified On: |
12/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study use of Bharanghyadi tail Nasya in Chronic Simple Rhinitis |
|
Scientific Title of Study
|
Open Randomised Controlled Clinical Study To Evaluate The Efficacy Of Bharanghyadi Tail Nasya in Kaphaja Pratishyaya w s r to Chronic Simple 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 Anuradha Shrihari Tarate |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic College PGT and RC Kodoli |
| Address |
Yashwant Ayurvedic College Post Graduate Training And Research Centre, Shalakya Tantra Department OPD Kodoli, Tal Panhala, Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7414960030 |
| Fax |
|
| Email |
anuradhatarate@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandrashekhar N Mule |
| Designation |
Head Of Department Shalakyatantra |
| Affiliation |
Yashwant Ayurvedic College PGT and RC Kodoli |
| Address |
Yashwant Ayurvedic College Post Graduate Training And Research Centre, Shalakya Tantra Department OPD Kodoli, Tal Panhala, Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9175800710 |
| Fax |
|
| Email |
drcnm05@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anuradha Shrihari Tarate |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic College PGT and RC Kodoli |
| Address |
Yashwant Ayurvedic College Post Graduate Training And Research Centre, Shalakya Tantra Department OPD Kodoli, Tal Panhala, Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7414960030 |
| Fax |
|
| Email |
anuradhatarate@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic College Post Graduate Training And Research Centre Kodoli Tal Panhala Dist Kolhapur Maharashtra 416114 |
|
|
Primary Sponsor
|
| Name |
Dr Anuradha Shrihari Tarate |
| Address |
Shalakya Tantra Department OPD and IPD Second Floor Yashwant Ayurvedic College Post Graduate Training And Research Centre Kodoli Tal Panhala Dist Kolhapur Maharashtra 416114 India |
| 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 Anuradha Shrihari Tarate |
Yashwant Dharmartha Rugnalay |
Shalakya Tantra OPD and IPD Second Floor Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Tal Panhala Dist Kolhapur 416114
Kolhapur
MAHARASHTRA |
7414960030
anuradhatarate@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comittee Yashwant Ayurvedic College PGT and RC Kodoli Tal Panhala Dist Kolhapur Maharashtra India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J310||Chronic rhinitis. Ayurveda Condition: KAPAJA-PRATISYAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Charak Samhita , Procedure details: Patient in supine position then udhrwang snehan & swedan after that installation of 4-4 drops of baladi tail in each nostril )
(1) Medicine Name: Baladi Tail, Reference: Shrushrut samhita uttartantra, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | nasyam, नस्यम् | (Procedure Reference: Charak Samhita , Procedure details: Patient in supine position then First urdhwag snehan & swedan after that tilt the head of patient installation of 4-4 drops of bharanghyadi tail in each nostril )
(1) Medicine Name: Bharanghyadi Tail, Reference: Charak samhita chikitsasthana, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient between the age group 18 to 60 yrs irrespective of gender, religion, occupation, socio-economic study will be selected randomly for the study.
2) Patient who gave written consent for study.
3) Patient having signs and symptoms of Kaphaja Pratishyaya and chronic simple rhinitis Nasa Strava, Nasa kandu ,Shiroguruta, Headache, Post nasal discharge.
|
|
| ExclusionCriteria |
| Details |
1)Patient with other systemic diseases k/c/o HTN, DM, Asthma, TB, AIDS , etc.
2)Patients other than Kaphaja Pratishyaya , Allergic Rhinitis, Atropic Rhinitis and other nasal disorder, Nasal polyp, Ca of nasopharynx etc.
3)Chronicity of disease more than 1 months.
4)Patient suffering from nasagat krumi, Gandh Gyan nashata, Drusta Pratishyaya, Apinas
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Evaluate the efficacy of Bharanghyadi Tail Nasya in Kaphaja Pratishyaya with special reference to Chronic simple Rhinitis |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the Kaphaja pratishyaya in detail from various Ayurvedic texts.
To study the Efficacy of Bharanghyadi Tail in signs of nasal discharge, itching of nose, heaviness in head in Kaphaja pratishyaya.
To asses improvement by gradation of Assessment Criteria.
To study the procedure of Nasya karma.
To achieve outcome of study in 15 days. |
15 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
10/05/2025 |
| 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="6"
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 is an Open Randomised Controlled Clinical Trial To Evaluate the Efficacy of Bhranghyadi Tail Nasya In Kaphaja Pratishyaya w.s.r to Chronic Simple Rhinitis . The assesment of signs and symptoms will be done at regular follow ups . Observations will be drawn from the outcomes achieved in 15days. |