| CTRI Number |
CTRI/2017/05/008657 [Registered on: 25/05/2017] Trial Registered Prospectively |
| Last Modified On: |
02/09/2026 |
| 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)
Modification(s)
|
Other (Terminated) |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The study was not initiated due to unavoidable reasons
|