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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
kandhaga rasayanam
Sponsored by
National institute of Siddha
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinea Infections Such as Tinea Corporis, Tinea Cruris, Tinea Pedis, Tinea Mannum, Tinea Barbae, Tinea Capitis Are Studied focused on measuring tinea

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National institute of siddha

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Kandhaga Rasayanam- single arm

Arm Description

Kandhaga Rasayanam- 2grams twice a day for 45 days

Outcomes

Primary Outcome Measures

skin scrapping test

Secondary Outcome Measures

itching, quality of life

Full Information

First Posted
September 10, 2014
Last Updated
September 10, 2014
Sponsor
National institute of Siddha
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1. Study Identification

Unique Protocol Identification Number
NCT02238912
Brief Title
Evaluation of Preclinical Toxicity andTherapeutic Efficacy of Kandhaga Rasayanam in Padarthamarai
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National institute of Siddha

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinea Infections Such as Tinea Corporis, Tinea Cruris, Tinea Pedis, Tinea Mannum, Tinea Barbae, Tinea Capitis Are Studied
Keywords
tinea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kandhaga Rasayanam- single arm
Arm Type
Experimental
Arm Description
Kandhaga Rasayanam- 2grams twice a day for 45 days
Intervention Type
Drug
Intervention Name(s)
kandhaga rasayanam
Other Intervention Name(s)
Siddha herbo mineral drug KR.
Intervention Description
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.
Primary Outcome Measure Information:
Title
skin scrapping test
Time Frame
45 days
Secondary Outcome Measure Information:
Title
itching, quality of life
Time Frame
45 days
Other Pre-specified Outcome Measures:
Title
burning sensation, vanishing of lesions
Time Frame
45 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
National institute of siddha
City
Chennai
State/Province
Tamilnadu
ZIP/Postal Code
600047
Country
India

12. IPD Sharing Statement

Citations:
Citation
AYUSH PORTAL, GOOGLE SCHOLAR
Results Reference
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Links:
URL
http://www.ctri.nic.in/
Description
TRIAL REGISTERED IN CTRI

Learn more about this trial

Evaluation of Preclinical Toxicity andTherapeutic Efficacy of Kandhaga Rasayanam in Padarthamarai

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