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A Phase III trial to assess the efficacy and safety of Boswellia serrata cream in Psoriasis

An open multicentric Phase III clinical trial to investigate the efficacy and safety of Boswellia serrata cream - A formulation for the management of Psoriasis.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/09/004030
Enrollment
200
Registered
2013-09-30
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: null- Subjects with mild to moderate Psoriasis

Interventions

Intervention1: Boswellia serrata cream: Cream to be applied topically thrice a day for 12 weeks Intervention2: Boswellia serrata cream: To be applied topically three times daily Intervention3: Boswell

Sponsors

Sami labs Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Informed Signed consent form 2 Patients aged 18 to 65 years 3 Patients with Mild to moderate Psoriasis

Exclusion criteria

Exclusion criteria: 1 Patients who have more than 50 percent of body surface area covered by psoriasis lesions 2 Patients on anticoagulant therapy 3 Use of immunosuppressive medication within past 2 month 4 Presence of other skin lesions like actinic ketoses or lentigo or photo damaged skin 5 Use of systemic or intralesional therapy or photo therapy for psoriasis in the previous Two months 6 Concomitant bacterial or fungal or viral skin infections 7 Pregnant or sexually active women who do not use contraception 8 Non-adherence to the treatment 9 Have history of renal or hepotobilary or malignant disease or hypertension or recurrent acute infection 10 History of any other evidence of severe illness or any other conditions that would make the patient in the opinion of the investigator unsuitable for the study

Design outcomes

Primary

MeasureTime frame
Extent of clearance of lesion Relief of symptoms Timepoint: Reduction in PASI Score Clinical Photographs Reduction in Biomarkers Global Evaluation by Doctor and Patient

Secondary

MeasureTime frame
Safety ProfileTimepoint: Change in Laboratory Parameters Adverse Events

Countries

India

Contacts

Public ContactMs Prachi Lad

ClinWorld(P)Ltd.

prachi@clinworld.org66981992

Outcome results

None listed

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