| CTRI Number |
CTRI/2020/09/027923 [Registered on: 21/09/2020] Trial Registered Prospectively |
| Last Modified On: |
18/09/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Nasya Karma in special type of Headache (Migraine) at the time of Menstrual Cycle |
|
Scientific Title of Study
|
Comparative study of efficacy of Shadbindu Tail and Dashamula Ghrita Nasya in the management of Migraine during Menstruation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhagyashri Vijay Chaudhari |
| Designation |
Assistant Professor |
| Affiliation |
MGACHRC Wardha |
| Address |
Department of Prasuti Tantra and Striroga
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha 442001
Department of Prasuti Tantra and Striroga
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9096415920 |
| Fax |
07152304545 |
| Email |
dr.bhagyashrichaudhari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shweta Parve |
| Designation |
Professor |
| Affiliation |
MGACHRC Wardha |
| Address |
Department of Panchakarma
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha 442001
Department of Panchakarma
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9403142270 |
| Fax |
07152304545 |
| Email |
drshwetaparve@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhagyashri Vijay Chaudhari |
| Designation |
Assistant Professor |
| Affiliation |
MGACHRC Wardha |
| Address |
Department of Prasuti Tantra and Striroga
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha 442001
Department of Prasuti Tantra and Striroga
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9096415920 |
| Fax |
07152304545 |
| Email |
dr.bhagyashrichaudhari@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College Hospital and Research Center Salod Hirapur near Hanuman Temple Yavatmal Road Wardha
A constituent unit of Datta Meghe Institute of Health Sciences Deemed to be University Wardha |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Ayurved College Hospital Research Centre Salod Wardha |
| Address |
Mahatma Gandhi Ayurved College Hospital Research Centre Salod Wardha |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Bhagyashri Vijay Chaudhari |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha |
Department of Prasuti Tantra and Striroga
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapura Wardha A constituent unit of DMIMS DU Wardha
Wardha
MAHARASHTRA |
9096415920
dr.bhagyashrichaudhari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Ayurved College Hospital Research Center Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N948||Other specified conditions associated with female genital organs and menstrual cycle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dashamula Ghrita |
Nasya with Dashamula ghrita 8 drops in each nostril once a day in morning hours
For the period of 15 days ( 10 days prior to probable date of Menses + 5 days of Menses)
Such 3 cycle treatment should be given
|
| Comparator Agent |
Shadbindu Tail |
Nasya with Shadbindu Tail 8 drops in each nostril once a day in morning hours
For the period of 15 days ( 10 days prior to probable date of Menses + 5 days of Menses)
Such 3 cycles of treatment should be completed
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patients with Specific feature of Menstrual migraine
Patient with age from Menarche to Menopause
|
|
| ExclusionCriteria |
| Details |
Sufferer of major disorders like hypertension, diabetes, hypothyroidism, severe anemia, irritable bowel syndrome, etc.
Patients having Migraine which is not related with Menstruation.
Patients of irregular menstrual cycle
Patients contraindicated for Nasya karma
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The effect of Nasya karma will be assessed with frequency of attack of migraine during menstruation. It is recorded as before Treatment (BT) and after Treatment (AT) |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The effect of Nasya karma will be assessed regarding the clinical signs and symptoms along with parameters. All subjective and objective parameters will be observed and recorded as before Treatment (BT) and after Treatment (AT) |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
21/09/2020 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Protocol published in The Journal of Critical Reviews |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients fulfilling criteria will be assigned into two groups by computerized randomization chart method group A and group B. Groups of Patients Group A (Trial group) Nasya with Dashamula ghrita 8 drops in each nostril once a day in morning hours For the period of 15 days ( 10 days prior to probable date of Menses + 5 days of Menses) Group B (Control group ) Nasya with Shadbindu Tail 8 drops in each nostril once a day in morning hours For the period of 15 days ( 10 days prior to probable date of Menses + 5 days of Menses) |