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A clinical trial to study the effects of two drugs, Palsinuron and Mahavatvidhwans ras in patients suffering from Migraine.

A Parallel two armed, randomized ,open labelled, Phase III Clinical study comparing the Palsinuron and Mahavatvidhwans ras in the management of Migraine (ARDHAVA BHEDAKA)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/06/002739
Enrollment
60
Registered
2012-06-25
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Migraine

Interventions

Intervention1: Palsinuron: Palsinuron Capsule ,one capsule twice a day for a period of 30 days Control Intervention1: Mahavatvidhwans ras: Mahavatvidhwans ras 125 mg, one capsule twice a day for a pe

Sponsors

SG Phytopharma Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age between 18 years and 60 years 2. Both the sex 3. Patient with five or more attacks of Migraine(headache) without Aura lasting for 4- 72 hours presenting with a) at least two of the features viz. i) unilateral, ii) Pulsating, iii) Moderate to severe, iv) Aggravated by movement and b) at least one of the features viz. i) Nausea, ii) Photophobia, iii) Phonophobia. 4. Patients willing to sign informed consent

Exclusion criteria

Exclusion criteria: 1. Age below 18 and above 60 years 2. Less than five attacks of Migraine without Aura. 3. Clinically diagnosed cases a. Tension headache b. Cluster headache. c. Idiopathic stabbing headache d. Exertional headache. e. Headache due to systemic infection. f. Drug induced headache 4. Organic brain lesions 5. Systemic disorders 6. Person undergoing treatment for any other serious illness. 7. Patient not willing to sign informed consent.

Design outcomes

Primary

MeasureTime frame
EfficacyTimepoint: 30 Days

Secondary

MeasureTime frame
SafetyTimepoint: 30 days

Countries

India

Contacts

Public ContactMrs B Sridevi

Sanjeevani Life Sciences

srinivas.lanka@sanjeevaniservices.com9989053518

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026