A Prospective Open-labelled, Non-Randomized, Phase -II Clinical trial of Kanduparangi Chooranam in the management of Iya Iraippu Noi (Bronchial Asthma)
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- If during treatment or after treatment reduction of the following symptoms
Study Overview
Brief Summary
The study is a prospective open labelled phase II non-randomized clinical study to evaluate the therapeutic efficacy of Kanduparangi Chooranam in the management of Iya Iraippu Noi( Bronchial Asthma).The trial drug will be administered at the dose of 60 mg/ Kg /BW/Twice a day A/F 30 days along with honey as adjuvant in 60 patients (30 in OPD and 30 in IPD).The trial period of 12 months will be carrying out in Government Siddha Medical College and Hospital Palayamkottai Tirunelvelli Tamilnadu. The primary outcome will be evaluation of therapuetic efficacy of trial drug Kanduparangi Chooranam. The secondary outcome will be the evaluation of Siddha diagnostic parameters,assessment of safety profile of trial drug,assessment of pharmacological and biochemical parameters of trial drug.In case of any adverse event (AE) is noticed and it will be referred to pharmacovigilance department of SCRI.Further management of patient will be given in OPD facility.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Open Label
Eligibility Criteria
- Ages
- 15.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patient with the symptoms of dry cough, recurrent attacks of dyspnoea,hoarseness of voice,frequent hemming,tightness of chest, profuse sweating & wheezing 2)H/o allergens, sneezing. 3)Patients who are willing to take radiological investigation and provide blood for lab investigation. 4)Patients who are willing to estimate volume of air forcibly expired after a deep inspiration by using Mini-Peak flow meter and PEFR below normal range from 250L/min to 150 l/min for men, from 200L/min to 100 L/min for women, for those patients are included. 7)Patients who are willing to do Spirometer study.
- •To estimate Pulmonary Function Test (PFT).
Exclusion Criteria
- •Pregancy 2)Lactating mother 3)Cardiac disease 4)Renal disease 5)Tuberculosis 6)Chronic bronchitis 7)Status asthmaticus 8)Diabetes mellitus 9)Auto immune disease.
Outcomes
Primary Outcomes
If during treatment or after treatment reduction of the following symptoms
Time Frame: 30 days
1.Dry cough
Time Frame: 30 days
2.Recurrent attacks of dyspnoea
Time Frame: 30 days
5.Tightness of chest
Time Frame: 30 days
7.Wheezing.
Time Frame: 30 days
3.Hoarseness of voice
Time Frame: 30 days
4.Frequent hemming
Time Frame: 30 days
6.Profuse sweating
Time Frame: 30 days
Secondary Outcomes
- 1.Evaluation of physicochemical, phyto chemical, bio chemical, pharmacological activities of “Kanduparangi Chooranamâ€.(2.Evaluation of siddha parameters (including Envagai thervu)changes in “IYA IRAIPPU NOI †during trial period.)