| CTRI Number |
CTRI/2020/06/025607 [Registered on: 04/06/2020] Trial Registered Prospectively |
| Last Modified On: |
28/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical study for Ayurvedic management of Migraine without Aura |
|
Scientific Title of Study
|
A Randomized Single-blind comparative clinical study to evaluate the efficacy of Marsha Nasya and Pratimarsha Nasya with Go sarpi in the management of Ardhavabhedaka with special reference to Migraine without Aura |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Divya Virupaksha |
| Designation |
PG scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Room no 306, Dept of Shalakya Tantra, Sri Sri College of Ayurvedic Science and Research, 21st km Kanakapura road, Udayapura post, Bangalore-82.
Bangalore
Karnataka
560082
India
Bangalore
KARNATAKA
560082
India |
| Phone |
9611611816 |
| Fax |
|
| Email |
myreports3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Virupaksha |
| Designation |
PG scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
663, 8th cross, 4th main, 4th stage, BEML Layout, Rajarajeshwari nagar, Bengaluru-98
KARNATAKA
560098
India |
| Phone |
9611611816 |
| Fax |
|
| Email |
myreports3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naveen B S |
| Designation |
HOD Associate Professor, Dept. of PG Studies in Shalakya Tantra. |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Room no 306, Dept of Shalakya Tantra, Sri Sri College of Ayurvedic Science and Research, 21st km Kanakapura road, Udayapura post, Bangalore-82.
Bangalore
Karnataka
560082
India
Bangalore
KARNATAKA
560098
India |
| Phone |
9844991405 |
| Fax |
|
| Email |
navs009@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic Science and Research Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Divya Virupaksha |
| Address |
663, 8th cross, 4th main, 4th stage, BEML Layout, RR nagar, Bangalire-98 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Divya Virupaksha |
Sri Sri College of Ayurvedic Science and Research Hospital |
Room no 6, OPD - Department of Shalakya Tantra, Sri Sri College of Ayurvedic science and research hospital, 21st km anakapura road Udayapura post Bangalore
Bangalore
KARNATAKA |
9611611816
myreports3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SRI INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G437||Chronic migraine without aura, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Marsha Nasya with Go Sarpi |
Marsha Nasya with Go Sarpi (Warm cow ghee)
Dose - 8 drops
Frequency - Once a day.
Route of administration - Nasal
Duration of therapy - 7 days
Procedure of Marsha Nasya
Purva Karma (1st stage):
Mridu Abhyanga with Murchita Tila Taila will be done on scalp, forehead, face, and neck followed by Nadi Sweda, with padded eyes.
Pradhana Karma (Second stage) :
Subject, with empty stomach is asked to lie down in supine position, with head slightly tilted back, and legs slightly raised. Marsha Nasya with the dosage of 8 Bindus will be administered to both nostrils, daily morning, in empty stomach with dose of 8 Bindus in each nostril for 7 Days.
Paschat Karma (Third stage):
Dhumapana with Haridra Dhuma Varti - Inhalation of medicated smoke through the nose and exhalation through mouth under supervision
Mrudu Sweda - Fomentation
Kavala - Gargling with warm water.
|
| Comparator Agent |
Pratimarsha Nasya with Go Sarpi |
Dose - 2 drops
Frequency - 4 times a day for 7 days
morning (praatah/talpotitah) after waking up, after breakfast, after lunch, and once in the night (nishi) before bed.
Route of administration - Nasal
Duration of therapy - 7 days
Procedure
Migraineur is supposed to instill two bindus of warm liquefied ghee daily in the morning (praatah/talpotitah) after waking up, after breakfast, after lunch, and once in the night (nishi) before bed. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Fresh and diagnosed cases of Migraine without aura.
2. Subjects aged between 21-60 years of age irrespective of gender, religion and occupation.
|
|
| ExclusionCriteria |
| Details |
1. Subjects contra-indicated for Nasya.
2. Pregnant and Lactating women.
3. Subjects with diagnosed conditions of Hemiplegic Migraine, Ocular/Retinal Migraine.
4. Subjects diagnosed with Pan-sinusitis.
5. Referred pain from ear and dental disorders, Eustachian catarrh.
6. Traumatic headaches.
7. Subjects with diagnosed Cranial tumor.
8. Headache due to systemic diseases like hypertension, hypoglycemia.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in migraine - Reduction in MIDAS SCORE |
After Treatment (8th day),
Follow up - 1 (15th day),
Follow up - 2 (30th day) of study period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in interval between attacks of Migraine without aura |
After Treatment (8th day), Follow up-1 (15th day), Follow up - 2 (30th day) of study period |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="9"
Days="28" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
Published at Journal of Interdisciplinary Cycle Research
Volume XIII, Issue IX, September/2021
ISSN NO: 0022-1945 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Migraine is a recurrent headache disorder with intense pain that may
be unilateral (one-sided) and accompanied by nausea
or vomiting as well as photosensitivity (sensitivity
to light) and phonosensitivity (sensitivity to
sound). Due to similarity of the signs and symptoms Migraine can be
understood as Ardhavabhedaka .
Common Migraine, that
is Migraine without aura, characterized by no
presence of early visual changes, dizziness, confusion, having pins or
needles in the skin sensation, forms roughly 75% of Migraine. Therefore,
the common Migraine has been selected for this study.
In
the contemporary medical system, one of the common medicines prescribed for
Migraine constitute long term use of Triptans, and NSAIDs.
Of
those taking Triptans -- patients listed sleepiness and
fatigue, racing heartbeat, nausea, and difficulty of thinking as common side effects.
NSAIDs
- Taking them daily can make headaches worse due
to medication overuse.
To
avoid the damage caused by them, there is a necessity for a safe effective
simple treatment modality in Ayurveda, which the study is aiming at.
Although there are
many studies completed on Ardhavabhedaka, this study is being taken up
to evaluate the treatment modality of Pratimarsha
Nasya. In the current scenario of peoples’ routine, Pratimarsha Nasya is a patient
friendly procedure as it does not require the patient to follow classical parihara
vishayas of Nasya, thereby enabling them to attend to their work
without interruption.
Snehana
Nasya is an indicated line
of treatment for Ardhavabhedaka. Marsha and Pratimarsha being the types of Snehana/Bruhmana Nasya
are the chosen modalities of treatment in this study.
Objectives of the study - 1. To re-evaluate the efficacy of Marsha Nasya with Go Sarpi in the management of Ardhavabhedaka. 2. To evaluate the
efficacy of Pratimarsha Nasya with
Go Sarpi in the management of Ardhavabhedaka. 3. To compare the
efficacy of Marsha Nasya and Pratimarsha Nasya with Go Sarpi in the management of Ardhavabhedaka.
HYPOTHESIS:
NULL
HYPOTHESIS:
Ho: Marsha Nasya and Pratimarsha
nasya with Go Sarpi have equivalent
effect in management of Ardhavabhedaka
(Migraine without Aura).
ALTERNATE
HYPOTHESIS:
H1 : Marsha Nasya and Pratimarsha
Nasya with Go sarpi do not have
equivalent effect in management of Ardhavabhedaka (Migraine without Aura).
|