Validation of homoeopathic drugs for migraine

Phase 3

• Conditions: Health Condition 1: null- Migraine

• Registration Number: CTRI/2018/05/014140
• Lead Sponsor: Central Council for Research in Homoeopathy New Delhi Ministry of AYUSH Government of India

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• At least 5 attacks of recurrent headache disorder fulfilling the following diagnostic criteria:

A. At least 5 attacks fulfilling criteria B-D

B. Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)

C. Headache has at least two of the following characteristics:

1. unilateral location

2. pulsating quality

3. moderate or severe pain intensity

4. aggravation by or causing avoidance of routine physical activity (e.g, walking or climbing stairs)

D. During headache at least one of the following:

1. nausea and/or vomiting

2. photophobia and phonophobia

E. Not attributed to another disorder

• HIT-6 score > 50

Exclusion Criteria

1. Diagnosed cases of sinusitis, cluster or tension headache, or any other ailment known to be closely associated with recurrent headache.

2. Pregnant or lactating women

3. Patients using regular migraine preventative medicines.

4. Patients with uncontrolled hypertension and diabetes.

5. Patient uses benzodiazepines or hormonal preparations.

6. Patients who abused stimulants or had an illness that made the practical participation in the trial difficult.

7. On allopathic drugs, other than for hypertension or diabetes mellitus

8. Other ongoing treatment which is likely to interfere with the course of this treatment.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To observe the change in Headache Impact Test (Hit-6) score at the end of 1 year of treatment.Timepoint: Baseline, 1 year

Secondary Outcome Measures

Name	Time	Method
To observe the change in Quality of Life (WHO-QoL) at the end of 1 year of treatment.Timepoint: Baseline, 1 year