To see effetiveness of homoeopathic medicines on chronic rhinosinusitis against placebo

Phase 2

Conditions: Health Condition 1: null- Chronic rhinosinusitis

Registration Number: CTRI/2012/01/002320

Lead Sponsor: Central Council for Research in Homoeopathy

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 120

Inclusion Criteria

1.Age group between 18-60 years from both gender.

2.Patients suffering from chronic rhinosinusitis (with or without nasal polyps) as defined in European Position paper on rhinosinusitis and polyps 2007.i.e.

-Presence of two or more symptoms one of which should be nasal blockage/ obstruction/congestion or nasal discharge (anterior/posterior nasal drip):

- facial pain/pressure

- reduction or loss of smell

for >12 weeks with validation by interview.

3 Written informed consent

4 Patients who can act in accordance with the protocol

Exclusion Criteria

1Patients who are not adequately symptomatic.

2Patients with serious underlying medical condition (eg. Severe renal or hepatic disease)

3Patients with history of malignancy.

4Patients taken any medication prior to entry into the study (can be enrolled after wash out period of 15 days).

5Patients taken topical steroids within 4 weeks before the study therapy (can be enrolled after wash out period of 1 month)

6 Atrophic rhinitis

7Complications of chronic rhinosinusitis

8Significant psychological problems

9Pregnant women

10 Lactating mother

11Do not give informed consent.

12H/o of underlying immunodeficiencies, cystic fibrosis, bronchiectasis, chronic obstructive pulmonary disease, diabetes mellitus, neoplasia or fungal sinusitis.

13Systemic diseases preventing participation in the study and medical and/or surgical treatments influencing the study.

14 No prior paranasal sinus, nose surgery.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
â?¢To assess the improvement in the TSS over 3 months with area under the curve. <br/ ><br>â?¢The changes from baseline to 3 months in the Sinus Nasal Outcome Test 22 (SNOT-22) <br/ ><br>Timepoint: â?¢To assess the improvement in the TSS over 3 months with area under the curve. <br/ ><br>â?¢The changes from baseline to 3 months in the Sinus Nasal Outcome Test 22 (SNOT-22) <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
â?¢Change in SNOT-22 at 6 months <br/ ><br>â?¢Objective clinical and laboratory outcome measures include changes in nasal endoscopy (at 3 months, 6 months) and CT scan (at 3 months). <br/ ><br>â?¢Changes in absolute eosinophilic count (AEC) at 3 months. <br/ ><br>â?¢No. of AE-CRS during observation period which includes endoscopic findings. Number of AE-CRS (FDI) in between groups. <br/ ><br>â?¢Changes in global assessment by patient and physician at 3 months and 6 months. <br/ ><br>Timepoint: 3 months, 6 months