CLINICAL RESEARCH ON SIDDHA MEDICINE IN IYA ERAIPPU NOI(BRONCHIAL ASTHMA)

Phase 3

Recruiting

• Conditions: IYA ERAIPPU NOI(BRONCHIAL ASTHMA)

• Registration Number: CTRI/2013/12/004253
• Lead Sponsor: AYOTHIDOSS PANDITHAR HOSPITAL

Brief Summary

It is a single, non-randomized, open-label trial to determine the efficacy and safety of ADATHODAI CHOORANAM in patients with IYA ERAIPPU NOI (BRONCHIAL ASTHMA). The trial drug Adathodai Chooranam is a herbal formulation taken from the classical Siddha text Book ‘Sigitcha Rathna Deepam Enum Vaidhya Nool’ Page No.118 & 119 which is a approved text Book of Drug and Cosmetics Act 1940.In this trial 125 Bronchial asthma patients will be recruited and the trial drug  will be administered 1.5 gm twice a day along with milk  for a period of 30 days. During this trial period all the study related data will be recorded and documented in a separate trial master file for each patients.During the trial period if any AE/SAE/SUSAR will be noticed and referred to pharmacovigilance dept.in NIS and further management will also be given in NIS OPD/IPD. The entire trial will be monitored by the research monitoring committee OF NIS. During this trial all the safety and efficacy parameters will be recorded in the CRF. After completion of the trial all the study related data will be analysed statistically .The out come of this trial will be published in Indian Journal of Medical Research.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-15
• Last Update Posted: 2013-12-19

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

• 1.Patients who are having classical symptoms of Bronchial Asthma that difficulty in breathing, Tightness of Chest, Wheezing, Dry (or) Productive Cough, 2.Only new patients will be included.
• 3.Aged between 15 to 60 years of both sexes.
• 4.Willing to give blood specimen, sputum, Radiological Investigation and Willing to be admitted in the hospital (or) attend the OPD once a week for 3 weeks.
• 5.Patients who are willing to estimate volume of air forcibly expired after a deep inspiration by using peak flow meter.

Exclusion Criteria

• 1.Pregnancy and Lactation period.
• 2.Significant Systemic illness including Cardiac Diseases, Renal Diseases, Hypertension.
• 3.Patients with only nasal block or rhinorrhoea.
• 4.Other respiratory Diseases such as Tuberculosis, Pneumonia, COPD,Bronchiectasis, cystic fibroisis, 5.Endocrine Disorders like Hypo & Hyper Thyroidism, Diabetes Mellitus 6.Status Asthmaticus.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Good response	PRE STUDY SCREENING AND AFTER 30 DAYS OF TREATMENT
Step4 Step1/Step2/Normal	PRE STUDY SCREENING AND AFTER 30 DAYS OF TREATMENT
Step4 to Step3	PRE STUDY SCREENING AND AFTER 30 DAYS OF TREATMENT
Moderate response	PRE STUDY SCREENING AND AFTER 30 DAYS OF TREATMENT
Poor response	PRE STUDY SCREENING AND AFTER 30 DAYS OF TREATMENT
Outcome	PRE STUDY SCREENING AND AFTER 30 DAYS OF TREATMENT
Step3Step1/Step2/Normal	PRE STUDY SCREENING AND AFTER 30 DAYS OF TREATMENT
PEEK EXPIRATORY FLOW MEASUREMENT	PRE STUDY SCREENING AND AFTER 30 DAYS OF TREATMENT
no Significant	PRE STUDY SCREENING AND AFTER 30 DAYS OF TREATMENT

Secondary Outcome Measures

Name	Time	Method
Eosinophils and ESR,	AEC, Serum IgE level

Trial Locations

Locations (1)

AYOTHIDOSS PANDITHAR HOSPITAL; 🇮🇳 Kancheepuram, TAMIL NADU, India

AYOTHIDOSS PANDITHAR HOSPITAL

🇮🇳Kancheepuram, TAMIL NADU, India

DR H VETHA MERLIN KUMARI

Principal investigator

9894782366

dr.vetha@gmail.com