Homoeopathic treatment of sinusitis

Phase 2/3

Completed

Conditions: Chronic sinusitis, unspecified, Non-surgical chronic rhino-sinusitis,

Lead Sponsor: National Institute of Homoeopathy Ministry of AYUSH Govt of India

Brief Summary: Chronic sinusitis is one of the mostprevalent chronic illnesses all over the world. An estimated134 million Indians suffer from chronic rhinosinusitis (CRS), 1 in 8 Indianssuffer from CRS. According to the,National Ambulatory Medical Care Survey, sinusitis is the fifth most commondiagnosis treated with antibiotics. Thus CRS has significant economicimplications. The small benefit gained for short duration may be masked by thenegative effects of antibiotics and the high recurrence rate of CRS. Homeopathymay hold promise in successful treatment of CRS, but has remainedunder-researched. In this double-blind, randomized, placebo-controlled,clinical trial at National Institute of Homoeopathy, 62 patients will berandomized to either individualized homoeopathic treatment + saline inhalation(n=31) or indistinguishable placebo + saline inhalation (n=31) to examinewhether individualized homoeopathy have any different effect from placebo intreatment of CRS. Sino-nasal Outcome Test 20 (SNOT-20) questionnaire (SNOT-20)scores, EQ-5D-5L scores, and 5 numeric rating scales measuring severity ofsneezing, rhinorrhoea, post-nasal drip (PND), facial pain or pressure, and lossof sense of smell will be assessed at baseline, after 2 months, and after 4months. Comparative analysis will be carried out to examine group differences,if any. Results will be published in scientific journals.

Recruitment & Eligibility

Inclusion Criteria

Patients of both sexes 2.
Patients of age between 18 and 60 years 3.
Patients having chronic rhino-sinusitis (CRS) since 12 weeks or more, fulfilling the diagnostic criteria of AAO-HNS.
Patients who have not taken any treatment since last 2 weeks for CRS.
Patients willing to take only homoeopathic medicines.

Exclusion Criteria

Patients suffering from other uncontrolled systemic diseases (like DM, Cancer and Thyroid diseases etc.), uncontrolled infections or any vital organ failure.
Patients suffering from the complications of CRS.
Patients who are insisting for or in need of surgical interventions.
Patients who are undergoing treatment with antibiotics, glucocorticosteroids or antihistamines during 2 weeks prior to enrolment in the study.
Psychiatrically unstable patients 6.
Self-reported immune-compromised patients 7.
Substance abuse and/or dependence 8.
Pregnant women and lactating mothers 9.
Already undergoing homoeopathic treatment for any chronic disease since last 6 months.

Primary Outcome Measures

Name	Time	Method
Sino-nasal Outcome Test 20 (SNOT-20) questionnaire (translated Bengali version)	Baseline, 2 months, 4 months

Secondary Outcome Measures

Name	Time	Method
EQ-5D-5L questionnaire (Bengali version)	Baseline, 2 months, 4 months
Five numeric rating scales (0-10) measuring severity of sneezing, rhinorrhoea, post-nasal drip (PND), facial pain or pressure, and loss of sense of smell	Baseline, 2 months, 4 months

Locations (1): National Institute of Homoeopathy, Govt. of India
🇮🇳
Kolkata, WEST BENGAL, India
National Institute of Homoeopathy, Govt. of India
🇮🇳Kolkata, WEST BENGAL, India
Pankhuri Misra
Principal investigator
8375089437
drpankhuri7hc@gmail.com