FindTrial
Sign In

â??An open label, single center, prospective clinical trial to assess the efficacy and safety of Safi Syrup manufactured by Hamdard Laboratories (INDIA) in the management of Acne Vulgaris.

â??An open label, single center, prospective clinical trial to assess the efficacy and safety of Safi Syrup manufactured by Hamdard Laboratories (INDIA) in the management of Acne Vulgaris in subjects by detoxification.â??

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/04/042147
Enrollment
30
Registered
2022-04-26
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

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

Conditions

Health Condition 1: L00-L99- Diseases of the skin and subcutaneous tissue

Interventions

Intervention1: Safi Syrup manufactured by Hamdard Laboratories (INDIA): oral Safi syrup 10 ml twice a day with follow up study visits at Day 1 days, Day 07, Day 21, Day 45, Day 75 and Day 90. Duration

Sponsors

Hamdard Laboratories
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Males and Females of age >=15and 2. Patient with signs of Acne Vulgaris. 3. Written informed consent signed by patient and willing to comply with the study procedure.

Exclusion criteria

Exclusion criteria: 1. Males and Females of age 30 years. 2. Pregnant or lactating women. 3. Patients with other variants of acne like Acne fulminans, Acne rosacea and Acne necrotica. 4. Patients who had previous history of hypersensitivity to Ayush drugs. 5. Serious hepatic or renal insufficiencies 6. Patients on treatment with other antibiotics corticosteroids, retinoid, anticonvulsants and androgens in the preceding four weeks. 7. Patients who are taking any hormonal preparations e.g. oral contraceptive pills. 8. Patient participated in new drug evaluation program in preceding 3 months. 9. Patients with apparent physical or mental abnormalities. 10. Any other condition that in the opinion of the Investigator, does not justify the patientâ??s participation in the study.

Design outcomes

Primary

MeasureTime frame
1.Improvement in Acne Vulgaris as per Acne grading method by Cook et al. using photographic standards and improvement in Leaky gut. 2.Improvement in clinical signs and symptoms of detoxification. 3.Global Assessment by investigator and patient for efficacy. Timepoint: Base Line, 7th day, 14th day, 21 day, 45th day, 75th day, 90th day.—

Secondary

MeasureTime frame
1. Type, number, frequency and proportion of patients with adverse event(s) and concomitant medication during the trial period (90 days). 2. Change in the laboratory investigations from screening visit to end of the trial CBC, LFT, RFT, RBS, HCG 3. Global Assessment by investigator and patient for tolerability. Timepoint: Base Line, 7th day, 14th day, 21 day, 45th day, 75th day and 90th day.—

Countries

India

Contacts

Public ContactDr Shaikh Khursheed Aalam

Masina hospital and research center

drkhursheedshaikh@gmail.com

Outcome results

None listed

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