Clinical research of Siddha medicine ATHIMATHURA CHOORNAM in Treatment of OTTRAI THALAIVALI(MIGRAINE)

Phase 2

Not yet recruiting

• Conditions: migraine(Oruthalai Avartham)

• Registration Number: CTRI/2017/05/008657
• Lead Sponsor: National institute of Siddha

Brief Summary

It is sigle arm AN OPEN CLINICAL TRIAL TO EVALUATE THE THERAPEUTIC EFFICACY OF SIDDHA HERBAL FORMULATION   â€œATHIMATHURA  CHOORNAM†IN THE TREATMENT OF ORUTHALAI AVARTHAM( MIGRAINE ). In this trail 40 migraine patients will be recruited and the trail drug will be administered 2 gram twice a day along with water for a period of 30 days.During the trail period all the study related data will be recorded and documented in a separate trail master file for each patients.During the study period if any adverse effect will be noticed and referred to pharmacovigilance dept in NIS aand further management will also be given in NIS OPDIPD. the entire trail will be monitored by research monitoring committee of NIS. During this trail all the safety and efficacy parameters will be recorded in the CRF. After completion of the trail all the study related data will be analysed statistically. The outcome of this trail will be published in Indian journal of Medical Research.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2017-05-24
• Study Start: 2017-06-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.Patients with complaints of Headache more than 6 months duration (untreated or unsuccessfully treated) 2.Nature of headache-Unilateral and Pulsating quality Moderate or severe pain intensity 3.Aggravation by or causing avoidance of routine physical activity 4.Headache associated with Nausea and/or vomiting Photophobia or Phonophobia.

Exclusion Criteria

1.Pregnant and Lactating women 2.Patient with anti-psychiatric treatment 3.Chronic Alcoholic patients 4.Hypertension, 5.Diabetes mellitus 6.Any systemic disease 7.Past history of head injury 8.History of Sinusitis 9.History of any space occupying lesion in brain.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The outcome is mainly assessed by clinical symptom, scoring HIT- Headache Impact Test questionnaire.	30 days
Reduction in the episode of headache, duration of headache, increase quality of life	30 days

Secondary Outcome Measures

Name	Time	Method
Influence of other co factors related to the disease such as Age, Sex, zodiac sign & stars etc..	Pre study screening and after treatment

Trial Locations

Locations (1)

Ayothidoss Pandithar Hospital; 🇮🇳 Kancheepuram, TAMIL NADU, India

Ayothidoss Pandithar Hospital

🇮🇳Kancheepuram, TAMIL NADU, India

Dr N Govindaraj

Principal investigator

8489040896

ngrsiddha91@mail.com