Evaluation of Preclinical Toxicity andTherapeutic Efficacy of Kandhaga Rasayanam in Padarthamarai (KR)

September 10, 2014 updated by: Dr.R.Meena, National institute of Siddha

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Tamilnadu
      • Chennai, Tamilnadu, India, 600047
        • National institute of siddha

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Kandhaga Rasayanam- single arm
Kandhaga Rasayanam- 2grams twice a day for 45 days
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.
Other Names:
  • Siddha herbo mineral drug KR.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
skin scrapping test
Time Frame: 45 days
45 days

Secondary Outcome Measures

Outcome Measure
Time Frame
itching, quality of life
Time Frame: 45 days
45 days

Other Outcome Measures

Outcome Measure
Time Frame
burning sensation, vanishing of lesions
Time Frame: 45 days
45 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National institute of Siddha

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • AYUSH PORTAL, GOOGLE SCHOLAR

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

September 10, 2014

First Submitted That Met QC Criteria

September 10, 2014

First Posted (Estimate)

September 12, 2014

Study Record Updates

Last Update Posted (Estimate)

September 12, 2014

Last Update Submitted That Met QC Criteria

September 10, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EXII(1)/29097/2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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

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