aiims final report AIIMS-final-report-Executive-Summary

Executive Summary
Project title: Randomized controlled clinical trial to evaluate prophylactic properties of Ayurvedic
Treatment Protocol in refractory and chronic migraine patients
Trial Registration Code: CT-57/011/RS
Project Code No.: N1343
Ethical clearance received on w.e.f.: 03-10-2011 (ref no. IEC/NP-276/2011)
Memorandum of Understanding (15-03-2012): Signed between Principal Investigator, Dean
(Research) from AIIMS and Ipca laboratories ltd., Mumbai (Sponsorer)
Principle Investigator: Prof. Dr. Manjari Tripathi, Dept. of Neurology, AIIMS, New Delhi
Co-Investigators: Prof. Dr. A. K. Mahapatra, HOD, Dept. of Neurology, AIIMS, New Delhi and
Vaidya Balendu Prakash, Ayurvedic Physician
Held at: Department of Neurology, All India Institute of Medical Sciences, Delhi
Project duration: 1 st April 2012 – 31 st May 2016
154 patients suffering from refractory/ chronic migraine were enrolled in the study (Table 1). These
patients were randomly treated in two stated groups; one with conventional prophylaxis (varied) and
rescue and second with Ayurvedic prophylaxis, consisting of Narikel Lavan 1 gm BD, NUMAX 1 BD,
Rason Vati 1 gm TDS and Godanti Mishran 250 mg OD for 4 months. No conventional prophylaxis was
given to this group. Both the groups were allowed to take rescue treatment as and when required.
Table 1: Demography of enrolled patients (n = 154)
Particulars
Sex (F : M)
Age Group
History (in years)
Frequency
(monthly)
Ayur Group (n = 77) Conv Group (n = 77)
2-4 53:24
18-62
1-28
35 58:19
18-55
1-20
26
> 4 42 51
Outcomes:





Ayurveda shows promising results in the treatment of Migraine in comparison to Ayurvedic
treatment
The recovery time was shorter for the Ayurvedic group (Table 2)
Significant reduction was observed in the frequency and intensity (Visual Analogue Score) of
pain
Migraine Induced Disability Assessment Score (MIDAS) was reduced significantly in the
Ayurvedic group
Sustainable and significant improvement was observed in the Ayurvedic group (Table 3 & 4)
Table 2: Treatment duration in both groups