| CTRI Number |
CTRI/2024/11/077133 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
12/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of homoeopathy in managing tension type headache. |
|
Scientific Title of Study
|
A Clinical Study on Effectiveness of Homoeopathic Medicines By Using Kent Repertory In The Management Of Tension Type Headache By Using IHS Diagnostic Criteria |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prodhoshini R |
| Designation |
PG Scholar |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department of Repertory opd room no 3C
Vinayaka Missions Homoeopathic Medical College and Hospital NH 47 Sankari main road seeragapadi po salem 636308
Salem
TAMIL NADU
636308
India |
| Phone |
8148820363 |
| Fax |
|
| Email |
prodhorajamani76@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Estherdevaramya |
| Designation |
Professor And Head Of The Department |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department Of Repertory opd room no 3C
Vinayaka Missions Homoeopathic Medical College and Hospital NH 47 Sankari Main Road Seeragapadi po salem
Salem
TAMIL NADU
636308
India |
| Phone |
9865191996 |
| Fax |
|
| Email |
estherdevaramya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Estherdevaramya |
| Designation |
Professor and Head Of The Department |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department Of Repertory opd room no 3C
Vinayaka Missions Homoeopathic Medical College and Hospital NH 47 Sankari Main Road Seeragapadi po salem
Salem
TAMIL NADU
636308
India |
| Phone |
9865191996 |
| Fax |
|
| Email |
estherdevaramya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Homoeopathic Medical College And Hospital
NH47 Sankari main road seeragapadi post Salem Tamilnadu 636308 |
|
|
Primary Sponsor
|
| Name |
Vinayaka mission homoeopathic medical college and hospital |
| Address |
NH 47 Sankari main road
seeragapadi
salem
Tamilnadu 636308 |
| Type of Sponsor |
Private medical college |
|
|
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 R Prodhoshini |
Vinayaka Missions Homoeopathic Medical College And Hospital |
Department Of Repertory Opd Room No 3C Vinayaka Missions Homoeopathic Medical College And Hospital NH 47 Sankari Main Road Seeragapadi Po Salem
Salem
TAMIL NADU |
8148820363
prodhorajamani76@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vinayaka Mission Kirupananda Variyar Medical College And Hospital Salem Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G442||Tension-type headache, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicine |
Homoeopathic Medicines Are Selected Based On Individualisation Of The Patient Potency Selected Based On The Susceptibility Of The Patient Medicine Is Administered Via Oral Route Followup Is Taken Once In Every One Month |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
All cases that fit into IHS diagnostic criteria (From ICHD - 3)
Subjects who have given consent for the study |
|
| ExclusionCriteria |
| Details |
Cases do not fit into IHS diagnostic criteria patients with psychiatric disorders pregnant and lactating mothers are excluded. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected that the proposal study will be useful in reducing severity of tension type headache |
At baseline and at the end of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assesment of patient with tension headache is done based upon the IHS diagnostic criteria and based on the pain numerating scale |
At baseline and at the end of study |
|
|
Target Sample Size
|
Total Sample Size="31"
Sample Size from India="31"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/12/2024 |
| Date of Study Completion (India) |
30/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Tension type headache is a neurological disorder and most common prevalent types of headache and important type of primary headache. It is a disabling and associated with some psychiatric co-morbidities. Various names such as muscle contraction headache psychomyogenic headache, ordinary headache, idiopathic headache. It is characterised by predispostion to attacker of mild to moderate headache with some associated symptoms. The diagnostic criteria for ISH are different and they are negation of those for migraine. For example, not bilateral, non pulsatting and not aggrasated by physical acting and so sometimes people experience types, migraine and TTH. Hence it is very necessary to study about the effectiveness of homeopathic medicines in the management of tension type headache curing the suffering humanity |