Effect of predetermined carbon group remedies in treatment of acne vulgaris: a pre-post clinical trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Global Acne Grading System (GAGS)
研究概览
简要总结
Acne vulgaris is a persistent chronic skin inflammatory condition affecting people all over the world, mostly adolescents and young adults. The Global Burden of Disease Study found that acne vulgaris is the eighth most common skin disease, with an estimated global prevalence (for all ages) of 9.38%. The visual appearance of acne and its sequelae, including scarring and pigment changes, frequently results in significant social and psychological morbidity with an increased risk of anxiety, depression, and suicidal ideation. Complementary and alternative medicines (CAM) are of increasing interest to people in acne therapy and generally regarded as safe. After thorough search in different databases few trials were identified regarding homoeopathic approach in acne management. Various homoeopathic literatures highly advocate the use of Carbo animalis, Carbo vegetabilis and Carboneum sulphuratum for treating acne cases. However in clinical practice these remedies are seldom used in acne therapy. Under such cicumstances, we intend to undertake a pre-post clinical trial to find out the effect of potentised homoeopathic medicine of carbon group namely Carbo animalis, Carbo veg and Carboneum sulphuratum as individualized homoeopathic medicines (IHMs) in cases of Acne vulgaris. A prospective, open label, single arm, pre-post clinical trial will be conducted on 39 participants of age group 12-30 years with complaints of acne vulgaris. The objectives are to detect the changes in Global Acne Grading System (GAGS), Cardiff Acne Disability Index (CADI) score at baseline, 3rd month and at 6 months and to analyse the comparative changes in mild, moderate, severe and very severe form of acne vulgaris with predetermined carbon group of remedies. The statistical analysis plan will follow the intension-to treat (ITT) approach. The score obtained from the patient on the said validated instrument before and after treatment will be compared and results will be analysed by using paired z-test. The result will be published in scientific journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 12.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •1.All the patients clinically diagnosed as having Acne vulgaris (ED80.Z).
- •2.Patients of both sexes between age group of 12-30 years.
- •3.Patients suffering from Acne vulgaris willing to participate and take treatment regularly and co-operating for regular follow-up will be included.
- •4.Acne vulgaris patients, after individualization most similar remedy found in any of the three predetermined carbon group of remedies (Carbo animalis, Carbo vegetabilis and Carboneum sulphuratum).
- •5.Patients knowing Bengali/English/Hindi.
排除标准
- •1.Patients of acne scars with co-morbid skin conditions like Psoriasis, Lichen planus, eczema etc.
- •2.Acne patients diagnosed with unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure.
- •3.Patient with substance abuse and/or dependence.
- •4.Patients under treatment with OCP, IUCD or NSAIDs. 5.Pregnant and lactating mothers.
- •6.Patient under the treatment of any other acne therapy.
结局指标
主要结局
Global Acne Grading System (GAGS)
时间窗: Baseline, 3rd month and 6th month
次要结局
- Cardiff Acne Disability Index (CADI)(Baseline, 3rd month and 6th month)
研究者
Paulami Sarkar
National Institute of Homoeopathy