A clinical trial on KUPPAIMENI CHOORANAM in the management of IRAIPPU IRUMAL(BRONCHIAL ASTHMA)

Phase 2

Completed

• Conditions: Other and unspecified asthma,

• Registration Number: CTRI/2021/02/031231
• Lead Sponsor: Government Siddha Medical College and Hospital

Brief Summary

The study is a Prospective  Open  labelled  phase  II non randomized  clinical  study  to evaluate  the therapeutic  efficacy of  KUPPAIMENI  CHOORANAM  in the  management  of IRAIPPU IRUMAL (BRONCHIAL ASTHMA). The trial drug  will  be  administered  at the dose of 30mg/Kg/BW /twice a day(orally) A/F 45 days along with Hot water as adjuvant in 60 patients. The trial  period  of 12 months will be carried out in Government  Siddha  Medical  College  and  Hospital, Palayamkottai, Tirunelveli, Tamilnadu. The primary outcome  will be  evaluation  of  therapeutic  efficacy  of  trial  drug  KUPPAIMENI  CHOORANAM. The  secondary  outcome  will be the evaluations 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  events (AE) is noticed and it will be referred to pharmacovigilance department  of SCRI.Further management  of patients will be given  in OPD facility.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-04
• Last Update Posted: 2022-01-06
• Study Completion: 2022-05-24

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1.Patient with the symptoms of dry cough, recurrent attacks of dyspnoea,hoarseness of voice,tightness of chest,profuse sweating and wheezing 2.History of allergens, climatic changes 3.Patients who are willing to take radiological investigation and provide blood for lab investigation.

Exclusion Criteria

1.Cardiac Diseases 2.Chronic allergic bronchitis 3.Tuberculosis 4.COPD 5.Pregnancy and Lactating mother 6.Restrictive airway disease 7.Status Asthmaticus 8.Systemic Hypertension 9.Autoimmune Diseases 10.Drugs and Chemicals.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
If during treatment or after treatment reduction of the following symptoms	45 days
1.Dry cough	45 days
2.Recurrent attacks of dyspnoea	45 days
3.Hoarseness of voice	45 days
4.Tightness of chest	45 days
5.Profuse sweating	45 days
6.Wheezing	45 days

Secondary Outcome Measures

Name	Time	Method
1.To evaluate the pharmacological activities	2.Study about the prevalence of Iraippu Irumal in relation between diet and life styles

Trial Locations

Locations (1)

Government Siddha Medical College and Hospital; 🇮🇳 Tirunelveli, TAMIL NADU, India

Government Siddha Medical College and Hospital

🇮🇳Tirunelveli, TAMIL NADU, India

Kalaiselvi Balakrishnan

Principal investigator

7907869866

kalaiselvibalakrishnan08@gmail.com