Safety study with special reference to heavy metal toxicity and dose determination study of Shwasakuthara Rasa- a herbomineral formulation.

Phase 1

• Conditions: Health Condition 1: J453- Mild persistent asthmaHealth Condition 2: J454- Moderate persistent asthma

• Registration Number: CTRI/2021/11/037824
• Lead Sponsor: All India Institute of Ayurveda

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Phase I- Healthy volunteers of either sex, age 20-60 years, belongs from same socio-economical condition, follow same dietary regimen and life style who willing to participate in the study will be enrolled after obtaining informed consent from each volunteer.

Phase II- Diagnosed case of mild and moderate persistent bronchial asthma who are willing to participate in this study by giving his/her consent during the course of work, Both the sexes having age between 20 years to 60 years.

Exclusion Criteria

Phase I-Healthy person who donâ??t want to participate, evidence of significant physical abnormalities, history of chronic medication within the past 6 weeks, history of hypersensitivity to any medication, regular smokers who smoke more than 10 cigarettes daily or have difficulty in abstaining from smoking during the study duration, history of drug dependence or chronic alcohol use, women with anticipated pregnancy/pregnant/lactating/ using oral contraceptives.

Phase II- Dyspnea resulting from other diseases like left ventricular failure, upper respiratory tract obstruction, bronchiectasis, cases of tuberculosis, interstitial lung disease/occupational lung disease, tropical pulmonary eosinophilia & allergic bronchopulmonary aspergillosis etc. Patients having anemia, pneumonia, tuberculosis, lung cancer, lung abscess and other such complicated conditions, Patients having diabetes, hypertension, Chronic and Acute renal failure etc. conditions in which urination is markedly diminished or excessive will be excluded, HIV, Pregnant/ lactating mother, Patient taking conventional medication.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
It will be helpful in generating evidence on maximum tolerable, safe and most effective dose of Shwasakuthara RasaTimepoint: Two years

Secondary Outcome Measures

Name	Time	Method
The observations will be helpful in framing relevant guidelines of drug use by drug regulating authorities.Timepoint: Two years