| CTRI Number |
CTRI/2025/09/095101 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
A clinical study to see how well customized homoeopathic medicine works for people with tension headaches, while also considering the triggers and factors that keep the headache going. |
|
Scientific Title of Study
|
A clinical prospecrive study of evaluating the effectiveness of individualized homoeopathhic medicine in tension type headache with consideration of exciting and maintaining cause. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gautami Anil Ohal |
| Designation |
PG Scholar |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University)HMC And Hospital Pune |
| Address |
Bharati Vidyapeeth(Deemed To Be University) HMC And Hospital, Department of Postgraduate and research center Pune 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
7887740988 |
| Fax |
|
| Email |
gautami.ohal-hmcpune@bvp.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinodini Patil |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University)HMC And Hospital Pune |
| Address |
Bharati Vidyapeeth(Deemed To Be University) HMC And Hospital, Department of Postgraduate and research center Pune 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
9890127840 |
| Fax |
|
| Email |
vinodini.patil@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gautami Anil Ohal |
| Designation |
PG Scholar |
| Affiliation |
Bharati Vidyapeeth(Deemed To Be University) HMC And Hospital Pune |
| Address |
Bharati Vidyapeeth(Deemed To Be University) HMC And Hospital, Department of Postgraduate and research center Pune 411043
Pune
MAHARASHTRA
411043
India |
| Phone |
7887740988 |
| Fax |
|
| Email |
vinodini.patil@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth(Deemed To Be University) Homoeopathic Medical College And Homoeopathic Hospital Pune 411043 |
|
|
Primary Sponsor
|
| Name |
Dr Gautami A Ohal |
| Address |
Bharati Vidyapeeth(Deemed To Be University) Homoeopathic Medical College And Homoeopathic Hospital, Department of Postgraduate and research center Pune 411043 |
| Type of Sponsor |
Other [Deemed to be university] |
|
|
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 Gautami Anil Ohal |
Bharati Vidyapeeth(Deemed To Be University) Homoeopathic Medical College And Hospital, Pune 411043 |
Bharati Vidyapeeth(Deemed To Be University) Homoeopathic Medical College And Hospital,Department of Postgraduate and research center, Dhankawdi, satara road, Pune 411043
Pune
MAHARASHTRA |
7887740988
gautami.ohal-hmcpune@bvp.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth(Deemed To Be University) Homoeopathic Medical College And Homoeopathic Hospital, Department of Postgraduate and research center Pune 411043 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G442||Tension-type headache, (2) ICD-10 Condition: G442||Tension-type headache, (3) ICD-10 Condition: G442||Tension-type headache, (4) ICD-10 Condition: G442||Tension-type headache, (5) ICD-10 Condition: G442||Tension-type headache, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homoeopathic medicine |
Individualized homoeopathic medicine after detailed case taking and dose and repetition depending on the case itself |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1 All socio economic status, ethnic group and occupations will be considered.
2 Both sexes with age group from 18-55 years of age group.
3 Individuals willing to give informed consent and comply with study procedure. |
|
| ExclusionCriteria |
| Details |
1 Secondary type of headache with underlying pathology and headache due to trauma or tumors
2 Patient with severe psychiatric or neurological disorders
3 The geriatric and pediatric age groups and pregnant and lactating females, Patient suffering from life threatening diseases and those who need emergency medical intervention
4 Comorbid migraine (with or without aura) & primary headache (cluster headache). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction in pain of tension type headache after intervention with individualized homoeopathic medicine. |
from baseline to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify the predominant exciting and maintaining causes on tension headache recurrence and intensity. |
From baseline to months. |
|
|
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
30/09/2025 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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 - NO
|
|
Brief Summary
|
Tension type of headache is one the most common headache which affects a large population globally which present as recurrent and bilatetal and pressing type of pain which is not aggravated by any routine activities based on Hahnemann’s principle hornoeopathy emphasizes Individualized treatment considering exciting causes like triggers and maintaining causes means factors prolonging disease In this study participants will be selected non randomly and after detailed case taking individualized medicine will be prescribed with oral administered and repeatition and dosage will be based on case and patients condition Study progress will be measured before after with assessment tools like headache impact test and numerical pain rating scale and at the end before after result and exciting and maintaining cause will be identified
|