Homeopathic treatment of eczema

Phase 3

Completed

• Conditions: Atopic dermatitis, unspecified,

• Registration Number: CTRI/2019/02/017576
• Lead Sponsor: D N De Homoeopathic Medical College and Hospital

Brief Summary

Atopic Dermatitis (AD) is a chronic, relapsing, pruritic, inflammatory skin disease having significant impact on the quality of life (QoL) and public health costs. Despite the fact that the evidences favouring homeopathy in AD is unconvincing, and based mostly on experience or anecdotal data, it is still highly popular. We evaluated whether individualized homeopathic medicines (IH) have significant effect beyond placebo in treatment of AD. A double-blind, randomized (1:1), two parallel arms, placebo-controlled trial (n=60) was conducted at D. N. De Homoeopathic Medical College and Hospital, West Bengal. Primary outcomes were patient-oriented scoring of AD (PO-SCORAD); secondary outcomes were dermatological life quality index (DLQI), and AD burden score for adults (ADBSA); measured at baseline, and every month, up to 3 months. Effect sizes (Cohen’s d, means adjusted for differences of baseline values) were calculated on intention-to-treat sample to detect group differences. Nine patients dropped out (IH: 3, Placebo: 6). Though intra-group changes were significant, between-group differences in PO-SCORAD, DLQI and ADBSA scores were non-significant (all P > 0.05, unpaired t test) except DLQI at month 1 (mean difference 1.3, 95% confidence interval (CI) 0.2 to 2.2, P = 0.019, unpaired t test, Cohen’s d = 0.6). Group difference on DLQI after 3 months (mean difference 1.9, 95% CI -0.1 to 3.9, P = 0.064, unpaired t test, Cohen’s d = 0.5) was near significant. Although the improvements produced by IH were higher than placebo, group differences were mostly non-significant. The trial being underpowered and of short duration, cautious interpretation is necessary.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-13
• Study Completion: 2019-05-29
• Last Update Posted: 2019-08-06

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients of 18-65 yrs of age 2.
• Both sexes 3.
• Suffering from atopic dermatitis as per UK diagnostic criteria for atopic dermatitis and POSCORAD more than 10 4.
• Patients already undergoing treatment for atopic dermatitis may be recruited on completely stopping medicine and after wash-out phase of 1 month 5.
• Literate patients 6.
• Signed written informed consent to participate.

Exclusion Criteria

• Patients too sick for consultation 2.
• Diagnosed case of unstable or psychiatric illness affecting quality of life (QoL) 3.
• Uncontrolled or life-threatening illness affecting QoL or any organ failure 4.
• Substance abuse and/or dependence 5.
• Pregnant and lactating women 6.
• Undergoing homoeopathic treatment for any chronic disease within last 6 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient Oriented Score of Atopic Dermatitis (PO-SCORAD)	At baseline, and every month up to 3 months

Secondary Outcome Measures

Name	Time	Method
Dermatology Life Quality Index (DLQI)	At baseline, and every month up to 3 months
Atopic Dermatitis Burden Scale for Adults (ADBSA)	At baseline, and every month up to 3 months

Trial Locations

Locations (1)

D. N. De Homoeopathic Medical College & Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

D. N. De Homoeopathic Medical College & Hospital

🇮🇳Kolkata, WEST BENGAL, India

Abdur Rahaman Shaikh

Principal investigator

7501030842

abdurrahamanshaikh6@gmail.com