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NCT02238912 Clinical Trial

Evaluation of Preclinical Toxicity andTherapeutic Efficacy of Kandhaga Rasayanam in Padarthamarai

Tinea Infections Such as Tinea Corporis, Tinea Cruris, Tinea Pedis, Tinea Mannum, Tinea Barbae, Tinea Capitis Are Studied Clinical Trial

— KR  

Official title:
Evaluation of Preclinical Toxicity of a Siddha Formulation Kandhaga Rasayanam ( KR ) and Its Therapeutic Efficacy in Padarthamarai ( Dermatophytoses ) by an Open Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02238912
Other study ID # EXII(1)/29097/2011
Secondary ID
Status Completed
Phase Phase 2
First received September 10, 2014
Last updated September 10, 2014
Start date June 2012

Study information
Verified date September 2014
Source National institute of Siddha
Contact n/a
Is FDA regulated No
Health authority India: Institutional Review Board
Study type Interventional

Clinical Trial Summary

this study is intended to find out the therapeutic efficacy of the siddha drug Kandhaga Rasayanam in Padarthamarai ( Ring worm infection )

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- patients clinically diagnosed with tinea infection.

- direct microscopy skin scraping test positive.

Exclusion Criteria:

- pregnant or nursing women.

- use of other topical or oral antifungals, immunosuppressive drugs, anthelmintic drugs either currently or during 2 weeks preceeding initiation of drug trial.

- allergy or hyperensitivity to any component of the drug.

- clinical case of eczema, lichen planus, pityriasis versicolor, drug induced eruptions, urticaria, intertrigo, tinea ungium.

- diabetic patients.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

  • Tinea
  • Tinea Capitis
  • Tinea Infections Such as Tinea Corporis, Tinea Cruris, Tinea Pedis, Tinea Mannum, Tinea Barbae, Tinea Capitis Are Studied
  • Tinea Pedis

Intervention

Drug:
• kandhaga rasayanam
KANDHAGA RASAYANAM is a siddha herbo mineral drug with sulphur as a sole mineral ingredient. It is chosen from the classic Siddha text Siddha Vaidhya Thirattu.

Locations
Country Name City State
India National institute of siddha Chennai Tamilnadu

Sponsors (1)
Lead Sponsor Collaborator
National institute of Siddha

Country where clinical trial is conducted

India, 

References & Publications (1)

AYUSH PORTAL, GOOGLE SCHOLAR

Outcome
Type Measure Description Time frame Safety issue
Other burning sensation, vanishing of lesions 45 days No
Primary skin scrapping test 45 days No
Secondary itching, quality of life 45 days No

External Links