Efficacy of individualized homeopathic medicines in the treatment of scabies in children and adults: A double-blind, randomized, placebo-controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Clinical cure: Improvement of lesions of scabies with no new lesions occurring since initiation of the treatment.
研究概览
简要总结
Scabies is caused by Sarcoptes scabiei var. hominis, a microscopic mite, spreads through direct skin to skin contact, is a highly contagious disease. In 2021, scabies contributes 5.3 million disability-adjusted life years (DALYs), which is a substantial contribution to the global burden of illness. In several Indian tribal populations, the prevalence of scabies is especially high, ranging from 6.9 to 20.6%. According to a 2010 study on dermatological diseases in Uttarakhand’s mountainous villages, 4.4% of people had scabies. The International Alliance for the Control of Scabies (IACS) has developed criteria to help with scabies diagnosis. Scabies can be effectively treated using topical and oral medications.Permethrin is much more effective and acceptable, but it is expensive and has several adverse effects. Despite the fact that homoeopathic drugs are widely used to treat scabies worldwide, there is still a lack of scientific studies to support their usage. In such conditions, we plan to conduct this study in order to assess the safety and efficacy of homeopathic remedies in the treatment of scabies. A double-blind, randomized (2:1), placebo-controlled trial will be conducted on 153 children and adults who are suffering from scabies at the outpatient’s department of D. N. De Homeopathic Medical College and Hospital. Assessment will be done by primary outcome measure which is to compare the proportion of participants revealing "clinical cure" that is disappearances of lesions of scabies and secondary measures (SKINDEX-29, CDLQI, and DLQI) are to detect the difference between the IHMs group and placebo group within 3 weeks of intervention. Group differences will be examined using appropriate statistical tests. The results will be published in scientific journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient suffering from scabies, and all household members and close contacts at the same time as the afflicted person.
- •Participants and/or guardians providing with written informed assent sand consent voluntarily.
- •Patients aged from 05-40 years.
- •Patients of either sex and transgender.
- •Clinical findings typical of scabies are burrows, erythematous papules, itching at night time, mite tunnels, macular or papular rashes with severe itching as main symptoms in web spaces, groin, other body parts, mite burrow in the webbed spaces of finger, flexor surface of wrist, elbows, axillae, belt line, feet, scrotum [male child], areolae [female child] etc.
- •Microscopic confirmation of scabies mite, ova, or mite faeces at classical sites by burrow ink test, KOH test and T-zanck smear.
排除标准
- •Denying written informed consent / assent voluntarily.
- •Simultaneous participation in any other clinical trial.
- •Participant with history of hypersensitivity reaction on any topical application.
- •Participant with other chronic disorders like juvenile diabetes, nephrotic syndrome, tuberculosis etc.
- •Associated with any other disease (immune-compromised state, AIDS, hepatitis etc.).
- •Secondary bacterial infection of scabies.
- •Norwegian scabies.
- •Cases of scabies in which the extent of an infestation cannot be reliably evaluated or cases where scabies co-exists with other skin diseases (e.g., atopic dermatitis, eczema, contact dermatitis, lichen planus, popular urticaria, seborrheic dermatitis) that may interfere with clinical assessment wise be excluded from the study.
- •The Skindex-29 score 26 and above.
- •Already undergoing homeopathic treatment for scabies or any other chronic diseases within last 2 months.
- •Patients who are too sick for consultation.
- •Pregnancy, puerperal women and lactating mother.
- •Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life.
- •Tobacco chewing and/or smoking, alcoholism and/or any form(s) of substance abuse and/or dependence (TAPS tool).
结局指标
主要结局
Clinical cure: Improvement of lesions of scabies with no new lesions occurring since initiation of the treatment.
时间窗: At baseline, and after 3 weeks
次要结局
- Skindex-29 questionnaire(At baseline, every week, up to 3 weeks)
- Children Dermatology Life Quality Index (CDLQI)(At baseline, every week, up to 3 weeks)
- Dermatology Life Quality Index (DLQI)(At baseline, every week, up to 3 weeks)
研究者
Dr Jahnabi Sardar
D. N. De Homoeopathic Medical College and Hospital