| CTRI Number |
CTRI/2017/05/008657 [Registered on: 25/05/2017] Trial Registered Prospectively |
| Last Modified On: |
24/05/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical research of Siddha medicine ATHIMATHURA CHOORNAM in Treatment of OTTRAI THALAIVALI(MIGRAINE) |
|
Scientific Title of Study
|
An open clinical trial to evaluate the therapeutic efficacy of Siddha herbal formulation “Athimathura choornam†in the treatment of Oruthalai avartham( migraine ) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr N Govindaraj |
| Designation |
PG Scholar |
| Affiliation |
National institute of Siddha |
| Address |
Room no 1 Department of Maruthuvam National Institution Of Siddha Tambaram sanatorium
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8489040896 |
| Fax |
04422381314 |
| Email |
ngrsiddha91@mail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T Lakshmigantham |
| Designation |
Lecturer |
| Affiliation |
National institute of Siddha |
| Address |
Department of Maruthuvam National Institution Of siddha Tambaram sanatorium
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9444466880 |
| Fax |
04422381314 |
| Email |
drlakshmiramaswamy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr N Govindaraj |
| Designation |
PG Scholar |
| Affiliation |
National institute of Siddha |
| Address |
Room no 1 Department of Maruthuvam National Institute Of Siddha Tambaram sanatorium
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
848904086 |
| Fax |
04422381314 |
| Email |
ngrsiddha91@gmail.com |
|
|
Source of Monetary or Material Support
|
| National institute of Siddha,Tambaram sanatorium chennai 600047 |
|
|
Primary Sponsor
|
| Name |
National institute of Siddha |
| Address |
National Institute of Siddha
Tambaram sanatorium chennai 47 |
| 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 N Govindaraj |
Ayothidoss Pandithar Hospital |
Room no 1 Department of Maruthuvam Ayothidoss Pandithar Hospital National institution of Siddha Tambaram sanatorium
Kancheepuram
TAMIL NADU |
8489040896
04422381314
ngrsiddha91@mail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
migraine(Oruthalai Avartham), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ATHIMATHURA CHOORNAM( INTERNAL MEDICINE) |
2 gram of ATHIMATHURA CHOORNAM will be administered orally twice a day with water for 30 days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with complaints of Headache more than 6 months duration (untreated or unsuccessfully treated)
2.Nature of headache-Unilateral and Pulsating quality Moderate or severe pain intensity
3.Aggravation by or causing avoidance of routine physical activity
4.Headache associated with Nausea and/or vomiting Photophobia or Phonophobia
|
|
| ExclusionCriteria |
| Details |
1.Pregnant and Lactating women
2.Patient with anti-psychiatric treatment
3.Chronic Alcoholic patients
4.Hypertension,
5.Diabetes mellitus
6.Any systemic disease
7.Past history of head injury
8.History of Sinusitis
9.History of any space occupying lesion in brain
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The outcome is mainly assessed by clinical symptom, scoring HIT- Headache Impact Test questionnaire.
Reduction in the episode of headache, duration of headache, increase quality of life
|
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
|  Influence of other co factors related to the disease such as Age, Sex, zodiac sign & stars etc.. |
Pre study screening and after treatment |
|
|
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 2 |
|
Date of First Enrollment (India)
|
28/06/2017 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is sigle arm AN OPEN CLINICAL TRIAL TO EVALUATE THE THERAPEUTIC EFFICACY OF SIDDHA HERBAL FORMULATION “ATHIMATHURA CHOORNAM†IN THE TREATMENT OF ORUTHALAI AVARTHAM( MIGRAINE ). In this trail 40 migraine patients will be recruited and the trail drug will be administered 2 gram twice a day along with water for a period of 30 days.During the trail period all the study related data will be recorded and documented in a separate trail master file for each patients.During the study period if any adverse effect will be noticed and referred to pharmacovigilance dept in NIS aand further management will also be given in NIS OPDIPD. the entire trail will be monitored by research monitoring committee of NIS. During this trail all the safety and efficacy parameters will be recorded in the CRF. After completion of the trail all the study related data will be analysed statistically. The outcome of this trail will be published in Indian journal of Medical Research.
|