Health Condition 1: G430- Migraine without aura
Conditions
Interventions
Intervention1: Group A: Oral formulation (edible oil): Mode of Administration:
- Participants should take four (4) drops of the oral medication twice daily (BID) after meals.
- Participants may incr
Sponsors
Savikalpa Sciences Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: Participants meeting all the following criteria will be eligible for the study: 1. Male and females, between 18 to 49 years of age (both inclusive); 2. Participants with a headache history for more than 1 year, 5 or more attacks of headache in 3 months; 3. Willingness to take the investigational product, following the dietary restrictions for the duration of the study; 4. Willing to complete the migraine diary.
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria will not be eligible for the study: 1. Participant with primary psychiatric disorders (schizophrenia, depression, anxiety, psychosis), major medical illness like renal, hepatic, neurological and cardiac diseases, pure menstrual migraine 2. Participants on Ayurveda or Yoga intervention for the past 6 months 3. Participants on conventional prophylactic treatment were excluded from the study 4. Known history of hypersensitivity to investigational product or its component 5. Pregnant women, lactating women, women of child bearing potential not following adequate contraceptive measures, women who were found positive for urine pregnancy test; 6. Any condition that in the opinion of the investigator does not justify the trial participant’s inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints of the study will be to calculate and assess: 1.Changes in MIDAS (Migraine Disability Assessment) scale score using migraine diary 2.Changes in Human Plasma Calcitonin Gene Related Peptide (CGRP) levels For 40 patients before and after treatment (10 subjects in each group) Timepoint: 1. at screening, day 30, 60 and 90. 2. at screening and day 90. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints of the study will be to assess: 1. Assessment of change in the requirement of rescue medication (Abortive migraine medications) 2. Changes in the number of headaches (No. of events) events and intensity (on 0-10 VAS) using migraine diary 3. Assessment of changes in Migraine Specific Quality of Life Questionnaire (MSQ) score Timepoint: 1. at baseline, day 15, 30, 45, 60, 75 and 90. 2. at day 15, 45, and 75. 3. at baseline and day 90. | — |
Countries
India
Contacts
Public ContactKshitij Bal
Savikalpa Sciences Pvt. Ltd.
Outcome results
None listed