THE EFFECT OF INDIVIDUALIZED HOMOEOPATHIC MEDICINES IN CENTESIMAL POTENCY IN COMPARISON WITH 50-MILLESIMAL POTENCY FOR THE TREATMENT OF PATIENTS HAVING ACNE VULGARIS: AN OPEN LABEL, RANDOMIZED DOUBLE-ARM STUDY
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Comparing the effects of individualised homoeopathic medicines prescribed in centesimal potency with individualised homoeopathic medicines prescribed in 50-millesimal potency.
研究概览
简要总结
Acne vulgaris is a common cutaneous inflammatory disorder of the pilosebaceous unit, which runs a chronic course. The condition typically manifests with papules, pustules, or nodules primarily on the face, although it can also affect the upper arms, trunk, and back. Along with its polymorphic clinical presentations, it has the potential to cause varying degree of scarring.Recent research has provided insights into the role of the sebaceous gland and the pro-inflammatory activity of the cutaneous microbiome. During puberty, alteration of the sebaceous lipid profile, called dysseborrhoea, stress, irritation, use of cosmetics and potential dietary factors lead to inflammation and formation of different types of acne lesions. Additionally, dysbiosis, the process leading to a disturbed skin barrier and disequilibrium of the cutaneous microbiome, resulting in the proliferation of P. acnes strains, is another important process that triggers acne. Following screening using specific selection (inclusion and exclusion criteria) criteria and obtaining consent, eligible 90 participants will be included in the trial (45 in each group). Individualized Homoeopathic medicines will be prescribed either in Centesimal potency or 50-millesimal (as per random number chart) after proper Case-taking, consultation with Materia medica and Repertory. Following that, the outcomes will be assessed initially at the baseline, and every one month up to 3 months, as per GAGS score, CADI scale and DLQI scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 10.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •All the patients clinically diagnosed as having Acne vulgaris [ICD11 code: ED80] characterised by comedones papules, pastules, nodules on face and trunk.
- •Age 10 to 50 years.
- •Both sexes and transgenders.
- •Patients giving written informed consent (for ages 18 to 50 years)/assent (for ages 10 to 17 years) to participate.
- •Patients with known but controlled systemic disease.
排除标准
- •Patients not giving written informed assent and/or consent to participate.
- •Patients using oil-based cosmetics for 6 months.
- •Patients under hormonal treatments.
- •Co-morbid skin conditions like Psoriasis, Lichen planus, eczema etc.
- •Vulnerable population – unconscious, non-ambulatory, too sick for consultation, differently abled, terminally or critically ill patients, mentally incompetent people.
- •Pregnant and puerperal women and lactating mothers.
- •Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure.
- •Substance abuse or dependence.
- •Self-reported immune-compromised state.
- •Undergoing homoeopathic treatment for any chronic disease within the last 6 months.
- •Simultaneous participation in any other clinical trial.
结局指标
主要结局
Comparing the effects of individualised homoeopathic medicines prescribed in centesimal potency with individualised homoeopathic medicines prescribed in 50-millesimal potency.
时间窗: At the baseline, and every one month up to 3 months.
次要结局
- 1. Assessment of life quality index.(2. Finding out multifactorial causation.)
