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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02238912
Recruitment Status : Completed
First Posted : September 12, 2014
Last Update Posted : September 12, 2014
Sponsor:
Information provided by (Responsible Party):
Dr.R.Meena, National institute of Siddha

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

Condition or disease Intervention/treatment Phase
Tinea Infections Such as Tinea Corporis, Tinea Cruris, Tinea Pedis, Tinea Mannum, Tinea Barbae, Tinea Capitis Are Studied Drug: kandhaga rasayanam Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2012
Actual Primary Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinea Infections

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 Name: Siddha herbo mineral drug KR.




Primary Outcome Measures :
  1. skin scrapping test [ Time Frame: 45 days ]

Secondary Outcome Measures :
  1. itching, quality of life [ Time Frame: 45 days ]

Other Outcome Measures:
  1. burning sensation, vanishing of lesions [ Time Frame: 45 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02238912


Locations
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India
National institute of siddha
Chennai, Tamilnadu, India, 600047
Sponsors and Collaborators
National institute of Siddha

Additional Information:
Publications:
AYUSH PORTAL, GOOGLE SCHOLAR

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Responsible Party: Dr.R.Meena, PhD Research scholar, National institute of Siddha
ClinicalTrials.gov Identifier: NCT02238912    
Other Study ID Numbers: EXII(1)/29097/2011
First Posted: September 12, 2014    Key Record Dates
Last Update Posted: September 12, 2014
Last Verified: September 2014
Keywords provided by Dr.R.Meena, National institute of Siddha:
tinea
Additional relevant MeSH terms:
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Tinea
Tinea Pedis
Tinea Capitis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Foot Dermatoses
Foot Diseases
Pruritus
Skin Manifestations
Signs and Symptoms
Scalp Dermatoses