CTRI/2025/12/098454尚未招募不适用
A randomized, controlled, parallel-arm, open-label clinical study comparing the efficacy and safety of sorozema oral-topical combination therapies in adults with mild to moderate plaque psoriasis.
Nisarga Biotech Pvt. Ltd.1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2025年12月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 试验地点
- 1
研究概览
简要总结
Plaque psoriasis is a chronic inflammatory skin disease with limited long-term relief from many existing treatments. Sorozema, an Ayurvedic multi-component formulation (capsule, oil, and cream), contains natural ingredients with anti-inflammatory, immunomodulatory, antioxidant, and skin-regulating properties. Early evidence suggests potential benefits in reducing psoriasis symptoms such as scaling, redness, and thickened skin. This clinical study aims to scientifically evaluate the safety, efficacy, and tolerability of Sorozema formulations in managing plaque psoriasis and determine whether combined oral and topical use offers improved therapeutic outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female participants aged 30 to 60 years inclusive.
- •2.A confirmed diagnosis of plaque psoriasis for at least 6 months involving the skin, scalp, or both, For group B the application of cream to scalp will not be recommended.
- •3.Participants diagnosed with plaque psoriasis with a PASI score must be between 3-20 both inclusive mild to moderate chronic plaque psoriasis.
- •Participants who have previously received topical corticosteroids or other topical antipsoriatic agents, provided they have completed the required washout period prior to randomization 2 weeks for topical corticosteroids and vitamin D analogs.
- •4.Participants who have not received systemic antipsoriatic therapy example methotrexate, cyclosporine, systemic corticosteroids, apremilast, or biologics within the required washout period prior to randomization typically 4 weeks for systemic corticosteroids and conventional systemic therapies 8–16 weeks for biologics.
- •5.Women of childbearing potential and men must agree to use adequate contraception hormonal or barrier methods, or abstinence before entering the study, during participation, and for at least 4 weeks after study withdrawal.
- •6.Ability to understand and willingness to sign a written informed consent document at the screening visit before any study-specific procedures.
排除标准
- •1.Prior use of TNF-alpha inhibitor therapy at any time before screening.
- •2.Presence of spontaneously improving or rapidly worsening plaque psoriasis, or diagnosis of acute guttate, pustular, inverse, or erythrodermic psoriasis, or psoriatic arthritis.
- •3.History or presence of any malignancy, including skin.
- •4.Serious dermatological infection within the past 3 months that required systemic therapy.
- •5.Any condition deemed by the investigator to pose risk or be detrimental to participation including but not limited to uncontrolled hypertension or severe cardiovascular, pulmonary (especially chronic obstructive pulmonary disease requiring steroid therapy), cerebral, hematologic, gastrointestinal, neurological, or psychiatric disorders.
- •6.Current use of medications known to worsen psoriasis, including Lithium, beta-blockers, antimalarials, or Nonsteroidal Anti-Inflammatory Drugs (NSAIDs).
- •7.Continuous use of Ayurvedic, Homeopathic, or Herbal products for at least 1 month, within the 3 months prior to screening.
- •8.Pregnant or lactating women.
- •9.History of substance abuse or heavy use of alcohol, drugs, or tobacco; 10.Any other condition, at the discretion of the investigator, that may interfere with the study results or compromise participant safety.
研究者
Dr Shraddha Patil
Ayushri Multispecialty Hospital
研究点 (1)
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