FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/04/042127 [Registered on: 25/04/2022] Trial Registered Prospectively
Last Modified On: 20/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Homoeopathic treatment of Tension-type headache  
Scientific Title of Study   Effectiveness of individualized homoeopathic medicines in treatment and improvement of Health-Related Quality of Life of patients suffering from Tension-type headache using Kents repertory: A single group, pre-post interventional study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Madhumita Nath 
Designation  Post Graduate Trainee 
Affiliation  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital 
Address  Department of Repertory, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Dr. B. N. Chakraborty Sarani, Dumurjola, Howrah

Haora
WEST BENGAL
711104
India 
Phone  8013442101  
Fax    
Email  dr.madhumitanath@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Samit Dey 
Designation  Professor  
Affiliation  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital 
Address  Department of Repertory, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Dr. B. N. Chakraborty Sarani, Dumurjola, Howrah

Haora
WEST BENGAL
711104
India 
Phone  9875371414  
Fax    
Email  dr.samit77@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Samit Dey 
Designation  Professor  
Affiliation  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital 
Address  Department of Repertory, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Dr. B. N. Chakraborty Sarani, Dumurjola, Howrah

Haora
WEST BENGAL
711104
India 
Phone  9875371414  
Fax    
Email  dr.samit77@gmail.com  
 
Source of Monetary or Material Support  
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Dr. B. N. Chakraborty Sarani,Dumurjola, Howrah- 711104 
 
Primary Sponsor  
Name  MADHUMITA NATH 
Address  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Dr. B. N. Chakraborty Sarani,Dumurjola, Howrah- 711104 
Type of Sponsor  Other [Self] 
 
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 
Madhumita Nath  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital  Medicine Outdoor Patient Department, Dr. B. N. Chakraborty Sarani,Dumurjola, Howrah- 711104
Haora
WEST BENGAL 		 8013442101

dr.madhumitanath@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  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 
Intervention  Individualized Homoeopathic medicine  Homoeopathic medicines will be selected based on the presenting complaints and the totality of symptoms. The medicine will be prescribed in centesimal potencies . The dosage will be composed of 6 globules moistened with indicated medicine to be administered at morning in empty stomach and duration of administration of medicine will be depending upon the susceptibility of the case that is one dose each at morning empty stomach for two days, followed by non medicated globules till improvement is seen. Repetition or change of medicine will be depending upon the prognosis of the case. All the medicines have been thoroughly proved and the details are written in Materia medica pura.  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  a) Self reporting patients with headache lasting for 30 minutes to 7 days (or more) for minimum of 6 months, fulfilling following criteria:
1) Two out of following
i) Bilateral headache
ii) Pressing/ tightening in quality
iii) Mild to moderate intensity
iv) Not aggravated by routine physical activity
2) Both of the associated symptoms
i) No Nausea and vomiting (anorexia may occur)
ii) No more than one of photophobia or phonophobia
b) Patient who can give consent
c) Patient who are not under homoeopathic
treatment for last 2 weeks
 
 
ExclusionCriteria 
Details  a) Abrupt onset of headache or change in their normal pattern or type of headache
b) Post traumatic headache and intractable headache
c) Patient on regular NSAID within 2 months of reporting
d) Any known systemic disease or uncontrolled diseases or infections affecting quality of life
e) Pregnant and lactating mothers
f) Substance abuse and/or dependence
g) Self reported cases of immune compromised state
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pain and disability assessment with Numeric Pain Rating Scale and Headache Disability Index Scale, respectively.  Baseline and at each follow up at an interval of 4 weeks for 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of quality of life using WHOQOL-BREF  Baseline and at each follow up at an interval of 4 weeks for 3 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   09/05/2022 
Date of Study Completion (India) Date Missing 
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)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. 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.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dr.madhumitanath@gmail.com].

  6. For how long will this data be available start date provided 01-11-2023 and end date provided 01-12-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Tension-type headaches (TTH)  are recurrent episodes of headache lasting for minutes to weeks. It is a variant of primary headache disorders. It has high prevalence and significant morbidity and it also lacks effective treatment modalities. There are very few clinical studies made in TTH in terms of treatment and headache related disability and its affect in quality of life, and there are insufficient evidences to support use of homoeopathy in management of TTH owing to deficient quality and quantity of literature and use of validated scales. So, this study  is undertaken to justify following question and hypothesis:
Research question: Are individualized homoeopathic medicine effective in treating and improving the health-related quality of life of patients with TTH?
Hypothesis: 
Null hypothesis: Homoeopathic medicines are not effective in treating and improving the health-related quality of life of patients with TTH
Alternative hypothesis: Homoeopathic medicines are effective in treating and improving the health-related quality of life of patients with TTH
 
Close