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CTRI Number  CTRI/2022/01/039567 [Registered on: 19/01/2022] Trial Registered Prospectively
Last Modified On: 18/01/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Role of Homoeopathy in Chronic Tension Type Headache according to the Temperament of the patient 
Scientific Title of Study   USEFULNESS OF HOMOEOPATHIC INTERVENTION BASED ON TEMPERAMENT PREDOMINANCE IN CHRONIC TENSION TYPE HEADACHE: A CLINICAL 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 KATHIKA CHATTOPADHYAY 
Designation  Professor HOD Psychiatry Incharge RnD Cell, BHMC&H, Greater Noida 
Affiliation  Bakson Homoeopathic Medical College & Hospital 
Address  Bakson Homoeopathic Medical College & Hospital Department of Psychiatry Room No. G 20. Ground Floor 36 B Knowledge Park 1 Greater Noida Gautam Buddh Nagar UP

Gautam Buddha Nagar
UTTAR PRADESH
201306
India 
Phone  9910860193  
Fax    
Email  dr.kathika@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR KATHIKA CHATTOPADHYAY 
Designation  Professor HOD Psychiatry Incharge RnD Cell, BHMC&H, Greater Noida 
Affiliation  Bakson Homoeopathic Medical College & Hospital 
Address  Bakson Homoeopathic Medical College & Hospital Department of Psychiatry Room No G 20 Ground Floor 36 B Knowledge Park 1 Greater Noida Gautam Buddh Nagar UP

Gautam Buddha Nagar
UTTAR PRADESH
201306
India 
Phone  9910860193  
Fax    
Email  dr.kathika@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr CP Sharma 
Designation  Principal 
Affiliation  Bakson Homoeopathic medical college & hospital 
Address  Bakson Homoeopathic Medical College & Hospital Room No G 22 Ground Floor 36 B Knowledge Park 1 Greater Noida Gautam Buddh Nagar UP

Gautam Buddha Nagar
UTTAR PRADESH
201306
India 
Phone  9899101747  
Fax    
Email  principal@bakson.net  
 
Source of Monetary or Material Support  
Bakson Homoeopathic Medical College & Hospital 
 
Primary Sponsor  
Name  Bakson Homeopathic Medical College and Hospital Greater Noida 
Address  Bakson Homoeopathic Medical College & Hospital 36 B Knowledge Park 1 Greater Noida Gautam Buddh Nagar UP 
Type of Sponsor  Private 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 Kathika Chattopadhyay  Bakson Homeopathic Medical college & Hosoital Greater Noida  LG1 LG 2 InPatient Department (IPD) Lower Ground Floor 36 B knowledge Park 1 greater Noida
Gautam Buddha Nagar
UTTAR PRADESH 		 9910860193

dr.kathika@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Bakson Homoeopathic Medical College  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  Case taking, remedy and potency selection, repetition schedule and change of potency will be followed as per guidelines of Organon of Medicine (5th edition) and related books of Homoeopathic Philosophy Data Collection: The patients will be followed up fortnightly and assessments would be made accordingly. Data analysis: Patients completing minimum of 3 months treatment with one assessment at baseline and then at 3 months would be included in the analysis. The patients not completing the minimum follow up or not complying with the study procedures will be dropped out from analysis.  
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  Patients suffering from Chronic Tension-Type Headache diagnosed according to ICHD-3(13)– which is:
Headache occurring on ≥ (13) days/month on average for >3 months (≥180 days/year)
Lasting hours to days, or unremitting
At least two of the following four characteristics:
bilateral location
pressing or tightening (non-pulsating) quality
mild or moderate intensity
not aggravated by routine physical activity such as walking or climbing stairs
 
 
ExclusionCriteria 
Details  Patients suffering in psychosis
Chronic headache from neurological disorder or systemic disorders.
Immuno-compromised patients and patients with substance abuse
Pregnant and lactating women’s
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To find out predominant temperament in cases of chronic type tension headache. [Time frame at baseline]  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Multidimensional perception of pain by assessing mean changes [Time frame Baseline/1st,2nd,3rd,6th month] includes the following aspects: a) sensory, description of pain in time-space terms; b) affective, description of pain in terms of stress, fear and neurovegetative aspects; and c) evaluative, pain described in terms of general assessment. (Higher the pain score greater the pain)
 		 Baseline, 1st, 2nd, 3rd, 6th Month 
 
Target Sample Size   Total Sample Size="67"
Sample Size from India="67" 
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)   01/02/2022 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Temperament and tension type headache
This study will be useful to find out the predominant temperament which predisposes a patient to get Tension type Headache.
Improvement is expected in the intensity, frequency and associated symptoms of tension type headache after giving appropriate Homoeopathic Medicine.
This study will further pave the path for further studies on Individualised medicine selection considering temperament predominance in other chronic diseases.
 
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