| CTRI Number |
CTRI/2023/07/055653 [Registered on: 25/07/2023] Trial Registered Prospectively |
| Last Modified On: |
28/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see the effect of Yoga techniques and Yoga techniques with Acupuncture for the management of Migraine headache. |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the effect of selected yoga techniques and acupuncture in migraine. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gahnavi C V |
| Designation |
PG Scholar |
| Affiliation |
JSS Ayurveda Medical College and Hospital |
| Address |
Room No. 08, Department of Swasthavritta, JSS Ayurveda Medical College and Hospital, #41/E, Lalithadripura, Mysuru - 570028
Mysore
KARNATAKA
570028
India |
| Phone |
9964684258 |
| Fax |
08212548360 |
| Email |
gahnavicv.pg21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Sudhakar Reddy |
| Designation |
Professor and Head |
| Affiliation |
JSS Ayurveda Medical College and Hospital |
| Address |
Room No. 08, Department of Swasthavritta, JSS Ayurveda Medical College and Hospital, #41/E, Lalithadripura, Mysuru - 570028
Mysore
KARNATAKA
570028
India |
| Phone |
9961483919 |
| Fax |
08212548360 |
| Email |
drpsreddy05@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Sudhakar Reddy |
| Designation |
Professor and Head |
| Affiliation |
JSS Ayurveda Medical College and Hospital |
| Address |
Room No. 08, Department of Swasthavritta, JSS Ayurveda Medical College and Hospital, #41/E, Lalithadripura, Mysuru - 570028
Mysore
KARNATAKA
570028
India |
| Phone |
9961483919 |
| Fax |
08212548360 |
| Email |
drpsreddy05@yahoo.com |
|
|
Source of Monetary or Material Support
|
| JSS Ayurveda Medical College and Hospital, #41/E, Lalithadripura Road, Mysuru- 570028 |
|
|
Primary Sponsor
|
| Name |
Dr Gahnavi C V |
| Address |
Department of PG Studies in Swasthavritta, JSS Ayurveda Medical College and Hospital, 41/ E, Lalithadripura Road, Mysuru, Karnataka, 570028
|
| 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 Gahnavi C V |
JSS Ayurveda College and Hospital |
Room NO. 8, Department of Swasthavritta OPD, 41/ E, Lalithadripura
Road, Mysuru, Karnataka, 570028
Mysore
KARNATAKA
Mysore
KARNATAKA |
9964684258
gahnavicv.pg21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS Ayurveda Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G439||Migraine, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Selected Yoga
Techniques |
Intervention period: 10 days.
After taking informed consent, Yoga will be demonstrated and asked to perform by the subjects as per the
prepared protocol.
Asanas- Tadasana, Vrikshasana, Vajrasana, Shashankasana, Baddhakonasan, Pavanamuktasana, Shalabanasana (ekapada and dvipada), Makarasana, Shavasana- 2 rounds each for 10 counts.
Time duration- 15 minutes.
Pranayama- Nadishodhana pranayama, Chandra anulomaviloma pranayama, Sitali & Bhramari- 5 rounds each.
Time duration- 10 minutes.
Meditation- Mindful meditation.
Time duration- 5 minutes.
Total time duration of Yoga practice - 30 minutes per day for 10 days. |
| Intervention |
Selected Yoga Techniques and Acupuncture. |
Intervention period: 10 days.
After taking informed consent, Yoga will be demonstrated and asked to perform by the subjects as per the prepared protocol mentioned in GROUP A and Acupuncture will be carried out in for a duration of 10 days.
Time period of Acupuncture: 30 minutes per day.
Duration-10 days.
No. of Sittings- 10.
Selection Of Needles:
Type of needle- Filiform needle.
Gauge of the needle- 36 gauge.
Length of the needle- ½ t-sun, 1 t-sun.
Quality of the needle- Stainless steel needles.
Selection Of Points:
Main points
1) GV-20
2) St-8
3) GB-8
4) GB-20
Supplementary points
1) LI-4
2) LI-11
3) St-36
4) St-40
5) Ex-6
6) Ear Shenmen
REQUIREMENTS:
Acupuncture needles- 20, Sterile cotton, Surgical spirit and Gloves
PROCEDURE:
Positioning of the Subject- Supine or Sitting.
In an Acupuncture room subjects will be positioned according to the requirement. Then the area of needle insertion is sterilized using surgical spirit. Needle will be held between the thumb and index finger. Tip of the needle will be taken near the acupuncture point and will be used rapidly for piercing the skin. After crossing the skin, the needle can be passed further with a firm rotation and pressure over it and if the needle has gone deeper, it can be withdrawn. After 30 minutes the needles will be removed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Subjects of either sex aged between 18 and 45 years of any religion, cast and socio-economic status.
Subjects suffering with migraine.
Subjects willing and able to participate in the study for 10 days. |
|
| ExclusionCriteria |
| Details |
Subjects having tension-type, idiopathic stabbing, exertional and cluster headache.
Subjects having any of the secondary type of headaches.
Patients with evidence of malignancy.
Subjects under medication for psychiatric disorders.
Acute cardiac arrythmias and Congestive cardiac failure.
Pregnant/ lactating mother.
Patients with poorly controlled Hypertension (>160 / 100 mm Hg).
Patients who have a history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
Alcoholics and / or drug abusers. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the duration & intensity of Headache. |
11th day & 31st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in MIDAS score & improvement in Quality of life questionnaire. |
11th day & 31st day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/09/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Migraine is characterised by periodic headaches which are typically unilateral and are often associated with visual disturbance and vomiting. It is one of the chronic illnesses. Migraine decreases the productivity of an individual. Not just the physical but it also affects his social life. Yoga is an ancient Indian discipline having holistic approach of restoring the abnormalities of body and mind. Acupuncture is also a non- pharmacological, safe and cost- effective intervention useful in treating different types of headaches. Even slight reduce in the intensity of headache makes a big difference for the patient. And the routine life of that individual will greatly differ. Hence, the present study is taken which is aimed to find the effect of Selected Yoga Techniques and Acupuncture in Migraine. Both Yoga and Acupuncture are economic and safe. In this study 40 subjects diagnosed with Migraine, diagnosed using ICHD-3, irrespective of gender will be randomly allocated into 2 groups. Group A-20 subjects and Group B- 20 subjects Intervention of the study: GROUP A Yoga will be demonstrated and asked to perform by the subjects as per the prepared protocol. Asanas: Tadasana, Vrikshasana, Vajrasana, Shashankasana, Baddhakonasan, Pavanamuktasana, Shalabanasana (ekapada and dvipada), Makarasana, Shavasana - 2 rounds each for 10 counts. Time duration- 15 minutes. Pranayama: Nadishodhana pranayama, Chandra anulomaviloma pranayama, Sitali & Bhramari - 5 rounds each. Time duration- 10 minutes. Meditation: Mindful meditation. Time duration- 5 minutes. Total time duration of Yoga practice - 30 minutes per day for 10 days. GROUP B Yoga will be demonstrated and asked to perform by the subjects as per the prepared protocol mentioned in GROUP A and Acupuncture will be carried out in for a duration of 10 days. PROCEDURE: Positioning of the Subject- Supine or Sitting. In an Acupuncture room subjects will be positioned according to the requirement. Then, as per the selected acupuncture points, the area of needle insertion is sterilized using surgical spirit. Needle will be held between the thumb and index finger. Tip of the needle will be taken near the acupuncture point and will be used rapidly for piercing the skin. After crossing the skin, the needle can be passed further with a firm rotation and pressure over it and if the needle has gone deeper, it can be withdrawn. After 30 minutes the needles will be removed. Time period of Acupuncture: 30 minutes per day. Duration-10 days. NOTE: During the period of intervention, subjects taking analgesics for more than 2 days will be dropped out from the study. Subjects are assessed on 0th day and on 10th day after the intervention, and again on 20th and 30th day as follow ups using MIDAS scale and Migraine Specific Quality of Life Questionnaire.
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