To study the effect of AYUSH AGT lotion in Dandruff.

Phase 1/2

Not yet recruiting

Lead Sponsor: central council for research in ayurvedic sciences ministry of ayush govt of india

Brief Summary: This study is a An Open LabelClinical Trial to Evaluate Clinical Efficacy and Safety of AYUSH AGT lotion in Dandruff(Darunaka). The medicine may beapplied on head every alternate day for a period of 30 days. The head may bewashed after 1 hr. Studysample size will be 50 patients for each center. It will be conducted in threecenters in India. Primary Outcome Measures is to assessthe efficacy of Ayush AGT Lotion in dandruff by means of Adherent ScalpFlaking Score (ASFS). Secondary outcome measures to seeSymptomatic improvement in Ayurvedic symptoms of Darunaka (dandruff)such as kesabhumi prapatana(flaking of scalp), Kandu(itching in scalp) andrukshata( dryness of scalp) by using Visual Analogue Scale (VAS), to see the Improvementin Quadrant Area Severity Scale and improvement in Dermatology Life QualityIndex (DLQI).

Recruitment & Eligibility

Inclusion Criteria

1.Patients of either sex in the age group 18-50 years 2.Patients diagnosed with mild to moderate dandruff, assessed by mean total Adherent Scalp Flaking Score (ASFS) of 8 zones in the scalp.
3.Dandruff restricted to the scalp with itchy, flaky skin without visible inflammation.
4.Patients willing to participate in the study for 45 days.

Exclusion Criteria

1.Patients diagnosed with severe dandruff.
Itching, flaking, pruritis and visible inflammation over face, retro-auricular area, and the upper chest.
2.Known C/O psoriasis.
3.Patients with inflammatory or infective scalp conditions 4.Patients with endocrine related diseases such as thyroid diseases which might cause hair fall.
5.Patients with uncontrolled Diabetes Mellitus having HbA1C > 8%.
6.Patients with history of hypersensitivity to hair products 7.Any other condition which the P.I. thinks may jeopardize the study.

Primary Outcome Measures

Name	Time	Method
To assess the efficacy of Ayush AGT Lotion in dandruff by means of Adherent Scalp Flaking Score(ASFS).	15th day and 30th day of study.

Secondary Outcome Measures

Name	Time	Method
ï¶Symptomatic improvement in Ayurvedic symptoms of Darunaka (dandruff) such as kesabhumi prapatana(flaking of scalp), Kandu(itching in scalp) and rukshata( dryness of scalp) by using Visual Analogue Scale (VAS).	ï¶Improvement in Quadrant Area Severity Scale.

Locations (3): egional Ayurveda Research Institute for Skin Disorders, Ahmedabad (RARISD)
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Ahmadabad, GUJARAT, India
Regional Ayurveda Research Institute for Metabolic Disorders (RARIMD), Bengalur
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Bangalore, KARNATAKA, India
Regional Ayurveda research institute for skin disorders, vijayawada
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Krishna, ANDHRA PRADESH, India
egional Ayurveda Research Institute for Skin Disorders, Ahmedabad (RARISD)
🇮🇳Ahmadabad, GUJARAT, India
Dr Kiran Deshbhratar
Principal investigator
9890746684
rarisd.amd-ayush@gov.in