Homeopathic medicines in sinus complaints

Phase 2/3

Recruiting

Conditions: Chronic sinusitis, unspecified,

Registration Number: CTRI/2021/02/031476

Lead Sponsor: D N De Homoeopathic Medical College and Hospital

Brief Summary: Chronic rhinosinusitis (CRS) is one of the most common chronic and debilitating conditions affecting 10-15% of the world population. An estimated 134 million Indians suffer from CRS. It has been shown to impair quality of life (QoL) and increase the risk of depression, anxiety, mood and sleep disorders and has significant morbidity and healthcare expenditure. Current management techniques mainly target to reduce inflammation with a variable results and endoscopic sinus surgery (ESS). Though homeopathy is one of the popular choice of CRS patients but effects of classical or individualized form of homeopathy (IH) remained unexplored through RCTs. In this double-blind, randomized, placebo-controlled trial at D. N. De Homoeopathic Medical College and Hospital, 40 patients suffering from CRS will be randomized to receive either individualized homoeopathic medicines (verum; n=20) or identical-looking placebo (control; n=20). We aim to address the feasibility issues of conducting a definitive efficacy trial of individualized homeopathy (IH) in treatment of CRS and to investigate whether there are any differences in outcomes between these two groups over 2 months of intervention. Sino-nasal Outcome Test-22 (SNOT-22) and EQ-5D-5L will be used as the primary and secondary outcome measures respectively. Feasibility issues will be checked and comparative analysis will be carried out to examine group differences, if any. Results will be published in scientific journals.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 40

Inclusion Criteria

Cases suffering from chronic rhinosinusitis for 12 weeks or more (2020 ICD-10-CM diagnosis code J32.9), but had not taken any treatment since last 2 weeks, and fulfilled the diagnostic criteria of AAO-HNS 2.
Age 18-65 years 3.
Patients of either sex 4.
Patients who are literate and capable of filling the questionnaire and providing written informed consent.

Exclusion Criteria

Cases suffering from uncontrolled systemic illness or life-threatening infections 2.
Cases suffering from complications of CRS 3.
Cases insisting for or in need of surgical interventions 4.
Cases already undergoing homeopathic treatment for any chronic disease 5.
Substance abuse and/or dependence 6.
Pregnant, puerperial or lactating women 7.
Patients with psychiatric diseases 8.
Self-reported immune-compromised states.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sino-nasal Outcome Test-22 (SNOT-22) questionnaire score	At baseline and after 2 months

Secondary Outcome Measures

Name	Time	Method
EQ-5D-5L questionnaire and VAS scores	At baseline and after 2 months

Trial Locations

Locations (1): D. N. De Homoeopathic Medical College and Hospital
🇮🇳
Kolkata, WEST BENGAL, India
D. N. De Homoeopathic Medical College and Hospital
🇮🇳Kolkata, WEST BENGAL, India
Sumana Sengupta
Principal investigator
9748192242
sumanaseng@gmail.com