Single arm clinical study to evaluate efficacy of Katutrikadi Churna in the management of Vataj Pratishyaya with special reference to Allergic Rhinitis
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- To evaluate efficacy of katutrikadi churna in the management of Vataj
Study Overview
Brief Summary
Aim - to evaluate efficacy of Katutrikadi Churna in the management of Vataj Pratishyaya with special reference to Allergic Rhinitis
Primary objectives –
To evaluate efficacy of katutrikadi churna in the management of Vataj
Pratishyaya with special reference to Allergic Rhinitis.
Secondary objectives-
- To study the clinical textual review of Vataj Pratishyaya in children
according to ayurveda and Allergic Rhinitis according to modern text.
- To study efficacy of katutrikadi churna in management of Vataj
Pratishyaya.
- To prepare katutrikadi churna as per vangsen samhita.
a) Study design – Single arm study
b) Study setting- patient will be selected randomly from OPD of kaumarbhritya
department in our hospital.
c) Duration of study- 18 months
Duration of treatment :- 7days
Follow up:- 3rd ,5th ,7th day
Diagnostic phase
Patient will be diagnosed on the basis of sign and symptoms of Vataj
pratishaya as per Ayurvedic text book (Nasavrodh Kshavathu
Nasasrava Shirshool etc )
Informed written consent will be taken prior to clinical study
Case will be recorded on specially designed proforma
Assessment phase
Subjective parameter :
a) Nasavrodh
b) Kshavathu
c) Nasasrava
d) Shirshool
Objective parameter : Absolute Eosinophil Count (if required)
After analyzing, data will be discussed in detail.
Conclusion will be drawn on the basis of data obtained and observation during study
Data will be summarized on the basis of observation and results
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 6.00 Year(s) to 12.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1 patient in age group of 6 to 12 years will be selected irrespective of sex, socioeconomic status and Religion 2 Allergic Rhinitis signs and symptoms.
- •3 patient suffering from Vataj Pratishyaya.
Exclusion Criteria
- •1 Rhinitis caused by infection and associated with nasal polyp, asthma, sinusitis, congenital anomalies and fever 2 Patients who need surgical and other intervention (nasal polyp, DNS) 3 Dusht, raktaj, sannipataj, kafaj pratishyaya.
Outcomes
Primary Outcomes
To evaluate efficacy of katutrikadi churna in the management of Vataj
Time Frame: 7 days
Pratishyaya with special reference to Allergic Rhinitis.
Time Frame: 7 days
Secondary Outcomes
- 1 To study the clinical textual review of Vataj Pratishyaya in children(according to ayurveda and Allergic Rhinitis according to modern text.)
Investigators
Dr Shubhangi Ram Bhosale
LRP Ayurvedic medical college and hospital, PG Institute and research centre urun Islampur