| CTRI Number |
CTRI/2025/03/082378 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic management of chronic tension headache. |
|
Scientific Title of Study
|
Effectiveness of individualized Homoeopathic medicine in management of chronic tension headache based on Dr. Kent evaluation of symptomatology: an open single arm interventional study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vibha Chaudhary |
| Designation |
Postgraduate Trainee |
| Affiliation |
State National Homoeopathic Medical College And Hospital |
| Address |
Department of Organon of Medicine. State National Homoeopathic Medical College and Hospital 1 Viraj Khand Gomti Nagar Lucknow.
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
7518914471 |
| Fax |
|
| Email |
vermavibha1920@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Vijay Kumar Pushkar |
| Designation |
Professor |
| Affiliation |
State National Homoeopathic Medical College and Hospital |
| Address |
Department of community medicine State National Homoeopathic Medical College and Hospital 1 Viraj Khand Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9415466529 |
| Fax |
|
| Email |
vijay04pushkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Vijay Kumar Pushkar |
| Designation |
Professor |
| Affiliation |
State National Homoeopathic Medical College and Hospital |
| Address |
Department of community medicine State National Homoeopathic Medical College and Hospital 1 Viraj Khand Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9415466529 |
| Fax |
|
| Email |
vijay04pushkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| State National Homoeopathic Medical College And Hospital 1 Viraj Khand Gomti Nagar Lucknow 226010 Uttar Pradesh India. |
|
|
Primary Sponsor
|
| Name |
Dr Vibha Chaudhary |
| Address |
Department of Organon of Medicine. State National Homoeopathic Medical College and Hospital 1 Viraj Khand Gomti Nagar Lucknow.pincode 226010 |
| Type of Sponsor |
Other [(Self)] |
|
|
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 Vibha Chaudhary |
State National Homoeopathic Medical College and hospital 1 viraj khand, gomtinagar Lucknow |
Department of Organon of Medicine and homoeopathic philosophy,OPD -5 , gomtinagar Lucknow-226010
Lucknow
UTTAR PRADESH |
7518914471
vermavibha1920@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee State National Homoeopathic Medical College and Hospital. |
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 |
Individualize Homeopathic Medicine |
Intervention-The Individualized homeopathic medicine will be selected according to Dr. Kent evaluation of symptomatology.
Dosage- Medicine will be given in varying potencies of decimal/centesimal/millesimal scales as identified from detailed case taking. Each dose shall consist of cane sugar medicated with single medicine. Route-medicine will be administered via oral route. Dosage and repetition will depend upon the individual requirement of the cases as per the guidelines from organon of medicine. The patient will be called for follow up after every 15 days and final assessment will be done after 6 months. At every follow up after reexamining the case it will be decided whether the patient will receive a dose of individualized homoeopathic medicine or Nil. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients fulfilling the diagnostic criteria of chronic tension headache.
2. Patients of age group between 18-60 years of age and patient of both sexes.
3. Patients from all religion and all socioeconomic condition.
4. Patients giving consent to participation.
5. History of tension headache for at least 3 months.
Clinically diagnose case of chronic tension headache. |
|
| ExclusionCriteria |
| Details |
1. Patient age below 18 years.
2. Patients who were not willing to come for follow up.
3. Patients having any serious medical illness.
4. Pregnant women and lactating Mothers.
5. Headache due to other etiology like Tumor Collagen vascular disease, Arteriovascular malformation and epilepsy.
6. MRI to diagnose any brain pathology.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study will give the role of individualized homoeopathic medicine effective in management of chronic tension headache. |
12 Weeks, 24 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in quality of life of patients by HIT - 6 Questionnaires administered at base line after 3 and 6 months. |
12 Weeks, 24 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
|
N/A |
|
Date of First Enrollment (India)
|
18/03/2025 |
| 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="6"
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
|
This is an open label single arm interventional study which aim to assess the utility of individualized. Homoeopathic medicine in the management of chronic tension headache. Individualized homoeopathic medicine will be prescribed after detailed case taking and repertorization. HIT-6 Questionnaires will be used before and after treatment and the difference will be compared and analyzed. Tension type headache are common with life time prevalence in general population ranging between 30 to 78%, in different studies they affect approximately 1.4 billion people or 20.8% of population Headache can affect people ability to work through decrease productivity and interpersonal relationships main class of drug to treat headache disorder include analgesic, Antiemetic, Anticonvulsant and Antidepressant medication, these medicine have many adverse effect in our body. In Homeopathy we always treat the patient with a holistic approach by considering the individuality of patient, in order to provide permanent relief in most reliable and harmless way. Therefore, the present study is undertaken to explore how individualized homoeopathic medicine useful by adopting Dr. Kent evaluation of symptomatology can prove to be useful in management of chronic tension headache and recurrence rate after homoeopathic treatment has been undertaken. |