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Clinical Evaluation of Efficacy & Safety of DRF/AY/5003 in comparison with marketed drug in Acne

An open, prospective, randomized comparative study to assess the efficacy and safety of DRF/AY/5003 with a marketed drug in various conditions.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/03/012727
Enrollment
300
Registered
2018-03-21
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L700- Acne vulgaris

Interventions

Intervention1: DRF/AY/5003: Rubia cordifolia, Hemidesmus indicus, Acacia catechu, Azadirachta indica, Curcuma longa, Smilax china, Tinospora cordifolia, Honey Control Intervention1: Safi: Bacopa Monni

Sponsors

Dabur India Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Subjects of either sex in the age group of 16-30 yrs mild to moderate acne Vulgaris 2 Subjects who signed informed consent form. 3 Subjects with ability to comply with all study requirements. 4 Subjects free of Diabetes and any other clinically significant diseases . 5 Subjects with normal Liver Function Tests and Renal Function Tests

Exclusion criteria

Exclusion criteria: 1 Subjects with severe acne vulgaris who require anti-infective therapies. 2 Subjects suffering from acne congloblata, endocrinal and other systemic disorders. 3 Subjects with a lot of facial hair. 4 Pregnant or lactating mothers. 5 Subjects with involvement in any concurrent study, the nature of which may affect the parameters being investigated in the study.

Design outcomes

Primary

MeasureTime frame
To assess the efficacy of DRF/AY/5003 in comparison with Safi, in relieving acne, hyper-pigmentation, dark circle & chronic idiopathic urticariaTimepoint: 12 weeks—

Secondary

MeasureTime frame
To assess the efficacy of DRF/AY/5003 in comparison with Safi, in relieving acne, hyper-pigmentation, dark circle & chronic idiopathic urticariaTimepoint: 12 weeks—

Countries

India

Contacts

Public ContactDr Arun Gupta

Dabur India Limited

arun.gupta@dabur.com01203378614

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026