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临床试验/CTRI/2024/12/078563
CTRI/2024/12/078563招募中2/3 期

Efficacy of Ekvimshati Guggulu and Khadirashthak Kwatha in combination with Durvadya Taila in the management of Vicharchika w.s.r. Eczema: an open-label randomised comparative study

Ayurvedic and Unani Tibbia College and Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年2月1日最近更新:

试验速览

阶段
2/3 期
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Proportion of participants achieving more than or equal to 50% improvement in EASI (Eczema Area and Severity Index) OR more than or equal to 6.6 point reduction in EASI score

研究概览

简要总结

Vicharchika (eczema), a chronic inflammatory skin condition, is categorized under Kshudra Kushtha in Ayurveda. It is characterized by symptoms such as itching (Kandu), discharge (Srava), vesicles (Pidika), dryness (Rukshata), and discoloration (Shyava Vrana). This condition, while not life-threatening, significantly impacts the quality of life, causing both physical discomfort and emotional distress. The psychological toll is substantial, as individuals with eczema often experience sleep disturbances, social withdrawal, and restrictions in daily activities.

The prevalence of eczema is notably high, affecting approximately 20% of children and 10% of adults worldwide. It ranks 15th among all non-fatal diseases in terms of disability-adjusted life years. Eczema is a highly prevalent, non-communicable chronic skin disorder with increasing incidence and recurrence rates. It is frequently associated with environmental, dietary, and psychological stressors, which contribute to its chronicity and progression.

Modern dermatological treatments, such as antihistamines, corticosteroids, and immunosuppressive therapies, primarily focus on symptom management but come with significant side effects, including skin thinning, nephrotoxicity, and increased susceptibility to infections. Additionally, these treatments often fail to address the root cause, and relapses are common, leading to long-term dependency on medications.

In contrast, Ayurveda offers a holistic approach to managing eczema by addressing the underlying imbalances in the Doshas (biological energies) and Dhatus (body tissues). Ayurvedic treatments aim to detoxify the body, restore balance, and promote natural healing. This study investigates the efficacy of Ekvimshati Guggulu, Khadirashthak Kwatha, and Durvadya Taila in the treatment of Vicharchika, focusing on their potential to provide long-term relief with minimal adverse effects. The study seeks to explore safer, more effective alternatives to conventional therapies and contribute to the growing body of evidence supporting Ayurvedic interventions for chronic skin conditions.

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
16.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1 Individuals with Eczema confirmed according to symptoms of Vicharchika explained in the ayurvedic texts (Brihattrayi) as well as the American Academy of Dermatology Criteria.
  • 2 Individuals of either gender aged 16 to 70 years
  • 3 EASI score less than or equal to 50.

排除标准

  • Populations with skin diseases other than eczema and Scabies, Seborrheic dermatitis, Contact dermatitis (irritant or allergic), Ichthyoses, Cutaneous T-cell lymphoma, Psoriasis, Photosensitivity dermatoses, Immune deficiency diseases, Erythroderma of other causes mentioned in exclusionary criteria of diagnostic criteria for Atopic Dermatitis in American Academy of Dermatology.
  • Cutaneous infection within 1 week before the screening visit or any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 1 week before the screening visit.
  • Patients with comorbid conditions such as known cases of Diabetes mellitus (Fasting blood sugar more than 126mg/dl), Grade 2 hypertension (BP more than 160/100mmhg), Renal impairment (Sr. creatinine more than 1.2 mg/dl), Hepatic impairment (SGOT and SGPT more than three times the upper limit).
  • Subjects with a history of any cardiovascular disease such as coronary artery disease, congestive heart failure, valvular heart disease, etc.
  • Subjects with comorbidities such as Tuberculosis, immunocompromised states such as HIV, history or active malignancy etc.
  • Pregnant women and lactating mothers.
  • Participants who had received topical corticosteroids, systemic steroids, immunosuppressants, and immunomodulators one month before screening.
  • Participants with a history of allergic reactions to ayurvedic drugs and those who exhibit sensitivity in the patch test to the topical medication.
  • Currently participating or participated in any other study of a drug, within the past 6 months before the screening visit.

结局指标

主要结局

Proportion of participants achieving more than or equal to 50% improvement in EASI (Eczema Area and Severity Index) OR more than or equal to 6.6 point reduction in EASI score

时间窗: Day 1, Day 91

次要结局

  • 1. Change in severity of dermatitis symptoms measured by vIGA-AD11(Validated Investigator Global Assessment scale for Atopic Dermatitis) and Itch NRS.(2. Change in serum IgE levels and AEC as a marker of allergic inflammation.)

研究者

发起方
Ayurvedic and Unani Tibbia College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Rubi Vishwakarma

Ayurvedic and Unani Tibbia College and Hospital

研究点 (1)

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