FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/06/069380 [Registered on: 24/06/2024] Trial Registered Prospectively
Last Modified On: 30/06/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Homoeopathic Treatment of Chronic Tension Type Headache 
Scientific Title of Study   The Efficacy of Individualized Homoeopathic Medicines in the Treatment of Chronic Tension Type Headache in Adults: A Double-Blind, Randomized, Placebo-Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1309-0836  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Krishanu Panja 
Designation  Postgraduate Trainee 
Affiliation  The Calcutta Homoeopathic Medical College & Hospit 
Address  Department of Practice of Medicine, Special OPD (Room no. 21), Medicine OPD (Room no. 16), 265-266 Acharya Prafulla Chandra Road Kolkata WEST BENGAL 700009 India

Kolkata
WEST BENGAL
700009
India 
Phone  9775256088  
Fax    
Email  krishanu.panja91@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. HIMANGSU HAIT 
Designation  Professor & Head of the Department of Practice of Medicine 
Affiliation  The Calcutta Homoeopathic Medical College and Hospital 
Address  Department of Practice of Medicine, Special OPD (Room no. 21), Medicine OPD (Room no. 16), 265-266 Acharya Prafulla Chandra Road Kolkata WEST BENGAL 700009 India

Kolkata
WEST BENGAL
700009
India 
Phone  9433565680  
Fax    
Email  haitdrhimangsu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. HIMANGSU HAIT 
Designation  Professor & HOD (Practice of Medicine) 
Affiliation  The Calcutta Homoeopathic Medical College and Hospital 
Address  Department of Practice of Medicine, Special OPD (Room no. 21), Medicine OPD (Room no. 16), 265-266 Acharya Prafulla Chandra Road Kolkata WEST BENGAL 700009 India

Kolkata
WEST BENGAL
700009
India 
Phone  9433565680  
Fax    
Email  haitdrhimangsu@gmail.com  
 
Source of Monetary or Material Support  
The Calcutta Homoeopathic Medical College and Hospital, 265-266, Acharya Prafulla Chandra Road, Kolkata 700009, West Bengal, India 
 
Primary Sponsor  
Name  The Calcutta Homoeopathic Medical College and Hospital 
Address  265-266, Acharya Prafulla Chandra Road, Kolkata-700009, West Bengal, India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Krishanu Panja  The Calcutta Homoeopathic Medical College and Hospital  Department of Practice of Medicine, Special OPD (Room no. 21), Medicine OPD (Room no. 16), 265-266 Acharya Prafulla Chandra Road Kolkata WEST BENGAL 700009 India Kolkata WEST BENGAL, India
Kolkata
WEST BENGAL 		 09775256088

krishanu.panja91@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethical Committee, Government of West Bengal, The Calcutta Homoeopathic Medical College and Hospital, 265-266, Acharya Prafulla Chandra Road, Kolkata 700009  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 with Concomitant Care  This group will receive placebo, identical in appearance with the verum. Each dose will consist of 1 cane sugar globules no. 40 moistened with 90% v/v ethanol, to be taken orally on clean tongue in empty stomach; dosage and repetition will be maintained depending upon the individual requirement of the cases.Both the groups of will be general advices on adequate dietary fibre, fluid intake, limit stress, heat therapy, build your support system and physical activity. All sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. Duration of therapy: 3months. 
Intervention  Individualized Homoeopathic Medicine with Concomitant Care  Intervention is planned as administering indicated homoeopathic medicines in centesimal potencies (Ch) as decided to the case or condition. Each dose will consist of 1 cane sugar globules no. 40 moistened with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on clean tongue in empty stomach; dosage and repetition depending upon the individual requirement of the cases. Patients will be advised to refrain from handling the globules or from eating, drinking, smoking, or brushing teeth within 30minutes 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 taking into account presenting symptoms totality, clinical history details, constitutional features, Miasmatic expressions repertorization using Synthesis repertory when required with due consultation of Materia Medica and due consensus among three homoeopaths. Along with medicine there will be general advices on adequate dietary fibre, fluid intake, limit stress, heat therapy, build your support system and physical activity. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. Durable of therapy: 3months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Age between 18 and 65 Years
2.Patients of either sex including transgender
3.The diagnosis of chronic tension type headache was based on The International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria for adults which were fulfilled for the past 3 months with symptoms onset at least 6 months before diagnosis.
4.Patient whose blood pressure is within the normal range
5.Illiterate people will be interviewed by the investigators maintaining adequate privacy to fill up the scales or questionnaires
6.Literate participant able to read and write in english, hindi or bengali
7.Participants having prior experience or knowledge of the treatment. E.g.- primed to expect ‘homoeopathic aggravation’ and available treatment options for the disease conditions, intimated through Patient Information Sheet. 
 
ExclusionCriteria 
Details  1.Criteria for migraine, Trigeminal autonomic cephalalgias or Other primary headache disorders fulfilled as per ICHD 3 for adults
2.Patients suffering from the complications of Tension Headache
3.Patients who are undergoing treatment with non-steroidal anti-inflammatory drugs (NSAIDs), antiemetic, or oestrogen during 2 weeks prior to enrolment in the study.
4.Diagnosed case of Cluster headache, Sinusitis, Brain aneurysm, Brain Tumour and Many other Pathologies
5.Has a history of structural abnormality of the Head or a disease or condition that can affect Headache
6.Unstable mental or psychiatric illness or other systemic diseases (e.g., uncontrolled hypertension, diabetes, thyroid diseases etc.) affecting quality of life or any vital organ failure
7.Patient under tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance abuse and/or dependence. (TAPS) Tool.
8.Self-reported immune – compromised state
9.Pregnant and puerperal women, and lactating mothers.
10.Patients who are too sick for consultation
11.Simultaneous participation of any other clinical trials.
12.Undergoing homoeopathic treatment for any chronic disease within the last 6 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 Disability Index, It measures specific symptoms of patients with Headache, consists of 25 Item Beta Version sub grouped into Functional and Emotional Subscale   Baseline and Every Month till 3 Months 
 
Secondary Outcome  
Outcome  TimePoints 
EQ-5D-5L, it is a standardized questionnaire used to measure health-related quality of life.  Baseline and Every Month till 3 Months 
 
Target Sample Size   Total Sample Size="144"
Sample Size from India="144" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="144" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   24/06/2024 
Date of Study Completion (India) 19/05/2024 
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)
Modification(s)  		 Completed 
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
Modification(s)  		 CTTH is a disorder evolving from frequent episodic tension-type headaches with daily or very frequent episodes of headache, typically bilateral, pressing or tightening in quality and of mild to moderate intensity, lasting hours to days or unremitting. The pain does not worsen with routine physical activity but may be associated with mild nausea, photophobia, or phonophobia. Tension-type headaches are very common, with a lifetime prevalence in the general population ranging in different studies between 30% and 78%. It has a high socio-economic impact. There is no clinical trial in homoeopathy that shows its effectiveness over the last 5 years. 144 eligible patients will be included in the trial. Following that, baseline outcome data (Headache Disability Index Scale, HDI questionnaire scores, and EuroQol 5 Dimension 5 Level, EQ-5D-5L questionnaire scores) will be obtained, and the patients will be randomised either to verum, IHMs or control (identical-looking placebo) in a 2:1 ratio. 
Close