A clinical trial to see the effects of Pathyadi Kwatha and Anu Taila Nasya in Patients withArdhavabhedaka (Migraine)

Phase 2

Not yet recruiting

Conditions: Migraine with aura, (2) ICD-10 Condition: G430||Migraine without aura,

Brief Summary: Migraine is a chronic neurological disordercharacterized by headache often unilateral and accompanied by nausea orvomiting as well as photosensitivity and phonosensitivity. Migraine causes great physical, and emotionalburden and is considered as one of the most disabling disease among all diseases.The disease is correlated with Ardhavabhedaka. It is considered to be atridoshaja Vyadhi. The conventional healthcare system provides temporary reliefin headache within hours. The Ayurvedic Pharmacopeia ofIndia has laid standards of Ayurvedic formulations appeared in AyurvedicFormulary of India. Oral administration of Pathyadi and Anu Taila Nasya are theformulations commonly used by Ayurvedic physicians in the management of Ardhavabhedakaand the pharmacopeial standards are available for both these formulations.Anu Taila Nasya has been taken as Nasya is considered as the remedy for Urdhvajatru gataVikara.

Recruitment & Eligibility

Inclusion Criteria

1.Patients of either sex aged in between 18 to 60 years.
2.Diagnosed cases of Migraine with aura /without aura as per as per International Headache Society-ICHD-III (International classification of Headache Disorders 3rd version).
3.Patients with up to Grade III on MIDAS Scale.
4.Frequency of headache is > two times in a month.
5.Willing and able to participate for 3 months (consent to be obtained from patients).

Exclusion Criteria

1.Patients who were suffering with headache due to space occupying lesions and other secondary reasons.
2.Patients with severe infection and/or clinically significant respiratory, cardiac or haematological disorders.
3.Hypertensive patients who are on Î² blockers.
4.Patients with uncontrolled Diabetes mellitus (HbA1C>8%).
5.Patients with uncontrolled Hypothyroidism (S.TSH>10mIU/ml).
6.Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT >3 times of the upper normal limit) or Renal Dysfunction (defined as S.
creatinine > 1.4 mg/dl) 7.Alcoholics and/or drug abusers.
8.Known cases of malignancy.
9.Pregnant women or planning to conceive or lactating woman.
11.Any other condition, which the PI thinks, may jeopardize the study.

Primary Outcome Measures

Name	Time	Method
To assess the Clinical Efficacy of Pathyadi Kwatha and Anu Taila Nasya in the management of Ardhavabhedaka (Migraine)	12 WEEKS

Secondary Outcome Measures

Name	Time	Method
To assess the Clinical Safety of Pathyadi Kwatha and Anu Taila Nasya in patients suffering with Ardhavabhedaka (Migraine)	12 WEEKS

Locations (2): Advanced Center for Ayurveda in Mental Health and Neuro Sciences(CCRAS)
🇮🇳
Bangalore, KARNATAKA, India
Central Ayurveda Research Institute for Cardiovascular Diseases(CCRAS)
🇮🇳
Delhi, DELHI, India
Advanced Center for Ayurveda in Mental Health and Neuro Sciences(CCRAS)
🇮🇳Bangalore, KARNATAKA, India
Dr Srinibash Sahoo
Principal investigator
09448941203
srinibash1970@gmail.com