Skip to content

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

Pharmaceutical Revalidation of Shwasakuthara Rasa and its Preclinical Safety and Phase I-II Dose Determination (Safety &Efficacy) Study

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/11/037824
Enrollment
60
Registered
2021-11-03
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

None listed

Sponsors

All India Institute of Ayurveda
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

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

Countries

India

Contacts

Public ContactNiladri Bhattacharjya

All India Institute of Ayurveda

prajapati.pradeep1@gmail.com8368797320

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026