Effect of Haridradi tail in Acne and Pigmentation

Phase 4

Completed

• Conditions: Postinflammatory hyperpigmentation. Ayurveda Condition: YUVANAPIDAKAÂ (MUKHADUSHIKA),

• Registration Number: CTRI/2022/01/039493
• Lead Sponsor: Ms Ozone Pharmaceuticals Ltd

Brief Summary

Haridradya Taila is a classical preparation mentioned in kshudra

rogadhikar of Chakradatta.iii .

This taila is indicated in conditions of Acne as well as Hyper pigmentation of facial skin.

Present study aims to Evaluate and Document the Efficacy and Safety of local application of Haridradya Taila in treatment of Acne and post inflamatory Hyperpigmentation .

Primary Objective –

1. To assess the efficacy of local application of Haridradya taila for its effect on mild to moderate Acne.

Secondary objective –

1. To assess the efficacy of local application of Haridradya Taila for its effect on Acne induced post inflammatory Hyper pigmentation.

2. To assess the safety and tolerability of local application of Haridradya Taila.



Assessment

For Efficacy Investigator’s Global Assessment (IGA) Scale for Acne Severity(Annex 1) Lesion counting (non inflammatory, inflammatory and total ) Acne induced Post inflammatory hyperpigmentation severity scale(Annex 2)For Safety and Tolerance Tolerance (0 – 3 point assessment scale)iv:Erythema, edema, scaling, dryness, burning, stinging & itchingPhotographs at baseline & 8 weeks: Findings will be compared andanalyzed for their significance to draw conclusion.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-31
• Study Completion: 2022-05-31
• Last Update Posted: 2022-07-24

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients of either sex having mild to moderate facial Acne and mild to moderate acne induced PIH in clinical features. ï‚· Patients of age between 18.
• 45 years. ï‚· Willing to take part in study and signing consent form.

Exclusion Criteria

• With Present History of Skin Disease e.g. Psoriasis, Dermatitis, Vitiligo etc.
• related to face.
• Person suffering from any infective or contagious skin disease 3.
• Under medication with antibiotics, antifungal and steroid during last one month.
• Women on Oral contraceptives 5.
• Patients of known uncontrolled hormonal disease.
• Any kind of diagnosed hereditary skin disorder.
• Patient who had undergone any type of skin treatment like laser therapy in last 6 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint – Changes from baseline to the end of trial period in	baseline, 4 weeks and 8 weeks
ï‚· Individual lesion count and overall lesion count in Acne	baseline, 4 weeks and 8 weeks
 Overall grading of Acne in Investigator’s Global Assessment scale for Acne	baseline, 4 weeks and 8 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary Endpoint	 –Changes from baseline to the end of trial period in Acne induced Post inflammatory hyperpigmentation severity scale

Trial Locations

Locations (1)

NIA Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

NIA Hospital

🇮🇳Jaipur, RAJASTHAN, India

Sumit Nathani

Principal investigator

7665809886

sumitnathani2@rediff.com