effect of Rasaushadhi and siravedhaprocedure in Headache.

Phase 2

Not yet recruiting

• Conditions: Migraine without aura,

• Registration Number: CTRI/2020/07/026557
• Lead Sponsor: National Institute of Ayurveda Amer road Jorawar singh gate Jaipur

Brief Summary

**This trial will be done to compare clinical efficacy ofSiravedha and Kumkumadi Ghrit Nasya along with Chandrakant Rasa inArdhawbhedaka wsr to Migraine. This is an interventional, Open clinical trial.The sample size is 30 with 2 groups, each group having a sample size of 15patients. In group A Kumkumadi Ghrita Nasya and chandrakant Rasa will begiven.  1 Tablets of 125 mg twice a day after food (250 mg/day) withwater for 7 days and 8-10 drop of Nasya for 7 day and again for 7 days with 7days gape, should be given. Duration of trial is 21 days. In groupB  Siravedha  done andchandrakant Rasa will be given. 1 Tablets of 125 mg of Chandrakant Rasagiven orally twice a day after food (250mg/day) with water for 7 days andSiravedha done once a week for two sittings. Duration of trial is 14 days. Theassessment of the clinical response in the total number of patients will bemade on subjective and objective parameters. Objective parametersinclude Laboratory Investigations:- CBC, RBS, ESR, LFT ,RFT , Fundusexamination, Vision test by snellens chart and refraction, IOP, CT, BT, HIV,HbsAg, X Ray PNS. Duration of Study will be 60 days (21 days trial+60 days follow up). Follow up for 2 months at 15 days interval aftercompletion of treatment.**

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-07-13
• Study Start: 2020-07-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 1.Patients willing to participate in this trial through written informed consent.
• 2.Patients between18 to 55 years of age from either sex.
• 3.Patients presenting with symptoms of Ardhavabhedaka/ Migraine described as per Ayurveda and modern science.

Exclusion Criteria

• 1.Secondary headaches caused by meningitis, tumors, encephalitis, head and neck trauma, trigeminal neuralgia, cervical spondylitis, refractive errors, sinusitis and other disorders of cranium, neck, eyes, ears, nose, sinuses, teeth etc.
• 2.Patients with complicated Migraine like status migrainosus, hemiplegic migraine and having any chronic debilitating disease with other neurological pathology.
• 3.Pregnant and lactating women.
• 4.Patients suffering from any other major systemic disorders e.g. tuberculosis, cancer, heart disease etc.
• Patients unfit for Siravedha such as patients with hemorrhagic diseases (e.g. hemophilia), anaemia, hypotension, severe allergic diathesis and on anticoagulant treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in clinical manifestation of Ardhawbhedak w.s.r.to migraine	21 days

Secondary Outcome Measures

Name	Time	Method
Changes in parameters of ardhawbhedak w.s.r.to Migraine	60 days.

Trial Locations

Locations (1)

national institute of ayurveda hospital; 🇮🇳 Jaipur, RAJASTHAN, India

national institute of ayurveda hospital

🇮🇳Jaipur, RAJASTHAN, India

Dr Ajay kumar nayak

Principal investigator

9993469939

ajaynayak9939@gmail.com