| CTRI Number |
CTRI/2025/08/092515 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to see how personalized homeopathic treatment helps people with tension headaches, measured by a headache impact scale HIT 6 |
|
Scientific Title of Study
|
An interventional study to assess the role of individualized homoeopathic medicine in the cases of tension-type headache using HIT6 scale |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vrinda Rana |
| Designation |
Post Graduate Resident |
| Affiliation |
Swasthya Kalyan Homoeopathic College and Research Centre |
| Address |
10-A, Sitapura Institutional Area, Tonk Road, Goner Road, Sitapura Industrial Area, Sitapura, Jaipur, Rajasthan 302022
Jaipur
RAJASTHAN
302022
India |
| Phone |
8171583668 |
| Fax |
|
| Email |
vrindarana99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukta Mala |
| Designation |
Associate Professor |
| Affiliation |
Swasthya Kalyan Homoeopathic College and Research Centre |
| Address |
A 13 Swasthya kalyan Hostel RIICO colony
Jaipur
RAJASTHAN
302022
India |
| Phone |
9999688407 |
| Fax |
|
| Email |
malamohan12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukta Mala |
| Designation |
Associate Professor |
| Affiliation |
Swasthya Kalyan Homoeopathic College and Research Centre |
| Address |
A 13 Swasthya kalyan Hostel RIICO colony
RAJASTHAN
302022
India |
| Phone |
9999688407 |
| Fax |
|
| Email |
malamohan12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swasthya Kalyan Homoeopathic College and Research Centre
10 A Sitapura Institutional area Jaipur |
|
|
Primary Sponsor
|
| Name |
Swasthya Kalyan Homoeopathic College and Research Centre |
| Address |
Swasthya Kalyan Homoeopathic College and Research Centre
10 A institutional area Sitapura jaipur |
| 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 |
| Vrinda Rana |
Swasthya Kalyan Homoeopathic College and Research Centre |
10-A, Sitapura Institutional Area, Tonk Road, Goner Road, Sitapura Industrial Area, Sitapura, Jaipur, Rajasthan 302022
10-A, Sitapura Institutional Area, Tonk Road, Goner Road, Sitapura Industrial Area
OPD Medicine 1 and 2 Room number 29, 30 Department medicine
Jaipur
RAJASTHAN |
8171583668
vrindarana99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SKHMCIEC |
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 |
Individualised Homoeopathic Medicine |
4-6 pills , pills number 30 , Route of Administration - oral, dose and repetition as per requirement of case, for 3 months |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Age group 16 to 45yrs of age
Both the sexes
All pre- diagnosed and new cases diagnosed cases of TTH diagnosed as per ICHD 3 will be included in the study
|
|
| ExclusionCriteria |
| Details |
The patients suffering from any other organic disease condition or taking medicines which could effect the outcome of the study
Patient who will refuse to give consent will be excluded from the study
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment done on pre and post score by using HIT6 scale and regular follow-up |
12 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The study will help to determine commonly prescribed Homoeopathic medicines for the management of Tension-Type headache. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
29/08/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 (TTH) is the most common primary headache, often affecting daily life. This open-label, single-arm interventional study will evaluate the role of individualized homoeopathic medicine in its management. Conducted over 12 months at Swasthya Kalyan Homoeopathic Medical College, Jaipur, the study will include 50 participants aged 16–45 years, diagnosed as per ICHD-3 criteria. Medicines will be prescribed after detailed case-taking and assessed using the HIT-6 scale every 28 days for 3 months. The study aims to determine the effectiveness of homoeopathy in reducing the impact of TTH and improving quality of life. |