| CTRI Number |
CTRI/2024/12/078309 [Registered on: 18/12/2024] Trial Registered Prospectively |
| Last Modified On: |
18/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathic treatment of tension type headache |
|
Scientific Title of Study
|
A double-blind, randomized, placebo-controlled trial to evaluate the efficacy of individualized homeopathic medicines using polarity analysis in the treatment of tension type headache in adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1316-3973 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tanay Sarkar |
| Designation |
Postgraduate Trainee |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept of Materia Medica, OPD room no. PG2, 12 Gobinda Khatick Road
Kolkata
WEST BENGAL
700046
India |
| Phone |
|
| Fax |
|
| Email |
sarkart1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Soumya Bhattacharyya |
| Designation |
Lecturer |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept of Materia Medica, OPD room no. PG2, 12, Gobinda Khatick Road
Kolkata
WEST BENGAL
700046
India |
| Phone |
9836998171 |
| Fax |
|
| Email |
soumya.bh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Soumya Bhattacharyya |
| Designation |
Lecturer |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept of Materia Medica, OPD room no. PG2, 12, Gobinda Khatick Road
Kolkata
WEST BENGAL
700046
India |
| Phone |
9836998171 |
| Fax |
|
| Email |
soumya.bh@gmail.com |
|
|
Source of Monetary or Material Support
|
| D N De Homoeopathic Medical College and Hospital 12 Gobinda Khatick Road Kolkata 700046 West Bengal India |
|
|
Primary Sponsor
|
| Name |
D N De Homoeopathic Medical College and Hospital |
| Address |
12 Gobinda Khatick Road Kolkata 700046 |
| Type of Sponsor |
Government 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 Tanay Sarkar |
D N De Homoeopathic Medical College and Hospital |
Dept of Materia Medica OPD no. PG2 and PG5, 12 Gobinda Khatick Road, Kolkata 700046
Kolkata
WEST BENGAL |
7501400691
sarkart1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of D N De 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 |
| Comparator Agent |
Identical looking placebo plus concomitant care |
This arm will receive placebo, indistinguishable in
appearance from verum. Each dose of placebo shall consist of 4 globules (no. 40).
of cane sugar, moistened with rectified spirit, to be taken orally on a clean tongue
with an empty stomach; dosage and repetition depending upon the individual requirement of the cases. Management guidelines will be given as in the experimental arm. Dosage: Individualized. Potency: Individualized. Route of administration: per oral. Duration of therapy: 3 months. Concomitant care: All the enrolled patients will receive advice on yoga therapy.
Both medicines and placebos will be repacked in identical glass bottles and labeled with the code, name of the medicine, and potency and will be dispensed according to the random number list. Concomitant care: All the enrolled patients will receive advice on yoga therapy. |
| Intervention |
Individualized homeopathic medicines in individualized dosages plus concomitant care |
The enrolled patients of TTH will be treated with IHMs
selected using polarity analysis with the help of BTPB to determine the most
appropriate remedy. It involves analyzing the patients symptoms and identifying their opposite symptoms or polar symptoms in a software named polarity
analysis’. The polar symptoms are those that have an opposite pole (e.g.
thirst/thirst, absent; cold worse/cold better). Most polar symptoms refer to
modalities that are peculiar and characteristic of the disease. At least 5 polar
symptoms and 10 remedies under the rubric will be taken into consideration in the application following the discard of contraindicated remedies, which will be in grey color in the previously named software. The most suitable remedies will
further be elicited with the help of Clarkes Materia Medica or Herings Guiding
symptom of our materia medica. Intervention is planned as administering indicated homeopathic remedy in centesimal potencies, as decided appropriate
to the case or condition. In centesimal scale, each dose shall consist of 4 globules.
(no. 40) of cane sugar, medicated with the indicated medicine (preserved in 90%
v/v ethanol) to be taken orally on a clean tongue with an empty stomach; dosage and
repetition depending upon the individual requirements of the cases. Patients will be advised to refrain from handling the globules or from eating, drinking, smoking or brushing teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. Single
individualized medicine will be prescribed on each occasion considering presenting complaint, location, sensation, modalities and concomitants using polarity analysis by Heiner Frei with due consultation of Materia medica. All medicines and sundries will be procured from a Good Manufacturing Practice
(GMP)-certified firm. Provision will be kept changing the medicines or potencies and adjusting the dosage in subsequent visits whenever required, following the principles of classical homeopathy, and such instances will be compared between
groups. Dosage: Individualized. Potency: Individualized. Route of administration: per oral. Duration of therapy: 3 months. Concomitant care: All the enrolled patients will receive advice on yoga therapy. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed TTH (ICD11- 8A81.Z) as per the third edition of the International
Classification of Headache Disorders (ICHD-3).
2. Age 18-65 years.
3. Participants of either sex or transgender.
4. At least 5 polar symptoms and 10 indicated remedies under a rubric. |
|
| ExclusionCriteria |
| Details |
1. Not willing to give written informed consent of participation.
2. Uncontrolled hypertension, diabetes or cancer or any other systemic illness,
or any vital organ failure.
3. Vulnerable population– unconscious, non-ambulatory, too sick for
consultation, terminally ill or critically ill, mentally incompetent people.
4. Pregnancy, puerperal women and lactating mother.
5. Tobacco chewing and/or smoking, alcoholism and/or any form(s) of
substance abuse and/or dependence (TAPS tool).
6. Self-reported immune-compromised state, AIDS, hepatitis etc.
7. Simultaneous participation in any other clinical trial.
8. Undergoing homoeopathic treatment for any chronic disease within the last 3
months. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Headache Impact Test-6 (HIT-6) |
Baseline and every month upto 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Headache Disability Inventory/Index (HDI) |
Baseline and every month upto 3 months |
| Measure Yourself Medical Outcome Profile version 2 |
Baseline and every month upto 3 months |
|
|
Target Sample Size
|
Total Sample Size="63"
Sample Size from India="63"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sarkart1997@gmail.com].
- For how long will this data be available start date provided 01-01-2027 and end date provided 31-12-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Tension type headache (TTH) (ICD11- 8A81.Z) ranks among the most prevalent causes of headaches globally. The analysis of 357 publications indicates that the estimated global prevalence of tension type headache (TTH) is 26.0% (ranging from 22.7% to 29.5%) with a prevalence of 23.4% among men and 27.1% among women. Homoeopathy is a frequently used therapy to treat tension type headache; however, the research evidence is limited. This double-blind, randomized, placebo-controlled trial is aimed at evaluating the efficacy of homeopathic medicines in the treatment of tension type headache in 63 adults. The primary outcome measure is HIT-6; the secondary outcome measures are HDI and MYMOP-2 questionnaires, all measured at baseline and every month up to 3 months. Comparative analysis will be carried out to detect the group differences. Results will be published in scientific journals. |