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CTRI Number  CTRI/2024/07/070775 [Registered on: 18/07/2024] Trial Registered Prospectively
Last Modified On: 16/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   To understand the effectiveness of homoeopathic medicine in treatment of head lice by giving medicine externally and internally  
Scientific Title of Study   An Analytical Study on Effectiveness of Homoeopathy in Pediculosis capitis as external application and internal Homoeopathic individualized medicine in children 
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 Kavya P B 
Designation  PG Scholar 
Affiliation  Sarada Krishna Homoeopathic Medical College 
Address  3RD FLOOR Room no 409 College Building, Department of Paediatrics Sarada Krishna Homoeopathic Medical College Kulasekharam Kanyakumari District Tamilnadu

Kanniyakumari
TAMIL NADU
629161
India 
Phone  8547423473  
Fax    
Email  kavyapb2705@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr P R Sisir 
Designation  Professor and HOD 
Affiliation  Sarada Krishna Homoeopathic Medical College 
Address  3RD FLOOR Room no 409 College Building, Department of Paediatrics Sarada Krishna Homoeopathic Medical College Kulasekharam Kanyakumari District Tamilnadu

Kanniyakumari
TAMIL NADU
629161
India 
Phone  9443474941  
Fax    
Email  hodpd@skhmc.org  
 
Details of Contact Person
Public Query  
Name  Dr P R Sisir 
Designation  Professor and HOD 
Affiliation  Sarada Krishna Homoeopathic Medical College 
Address  3RD FLOOR Room no 409 College Building, Department of Paediatrics Sarada Krishna Homoeopathic Medical College Kulasekharam Kanyakumari District Tamilnadu

Kanniyakumari
TAMIL NADU
629161
India 
Phone  9443474941  
Fax    
Email  hodpd@skhmc.org  
 
Source of Monetary or Material Support  
Sarada Krishna Homoeopathic Medical College Kulasekharam Kanyakumari District Tamilnadu 629161 
 
Primary Sponsor  
Name  Sarada Krishna Homoeopathic Medical College 
Address  Sarada Krishna Homoeopathic Medical College Kulasekharam Kanyakumari District Tamilnadu 629161 
Type of Sponsor  Research institution and hospital 
 
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 Kavya PB  Sarada Krishna Homoeopathic Medical College  Room No 409 Department of Paediatrics Sarada Krishna Homoeopathic Medical College Kulasekharam Kanyakumari district Tamilnadu
Kanniyakumari
TAMIL NADU 		 8547423473

kavyapb2705@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee Sarada Krishna Homoeopathic Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pediculosis Capitis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  External Application of Homoeopathic medicine  Group 1 - Will be administered externally with 5 drops of mother tincture in 20ml of aqua daily night for 2 weeks 
Comparator Agent  Homoeopathic Medicines  Group 2 - Will be administered internally by individualized homoeopathic medicine 30 and 200 Potency administered orally at morning hour repeated once in two weeks 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Age group 1 to 18 years
Both genders
Child showing the characteristics clinical feature of pediculosis capitis were taken 
 
ExclusionCriteria 
Details  Age less than 1 years and above 18 years
Those who are taking other medications for pediculosis capitis 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Decrease in the severity of symptoms will serve as a means for assessing the progress  The outcomes will be assessed once in two weeks during the trial period  
 
Secondary Outcome  
Outcome  TimePoints 
The outcome will be done as per susceptibility and improvement status  The outcomes will be assessed once in a month during the trial period  
 
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 3/ Phase 4 
Date of First Enrollment (India)   28/07/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   Pediculosis  capitis is a ubiquitous parasitic skin disease associated with intense pruritus of the scalp. In developing countries it frequently affects children and adults. but epidemological data at the community level are rare. Pediculosis capitis is a human head lice infestation, a major public health issue that is most prevalent in resource-limited countries globally. Pediculosis capitis is infestation by head lice that is a major public health problem globally which is most prevalent in low-income countries, It is an omnipresent issue in children in both schools and in the broader community. Pediculus capitis can cause loss of sleep, irritation, pruritus, discomfort, secondary bacterial infections and lymphadenopathy. The head lice are a potential vector for disease-causing organisms such as Rickettsia prowazekii, Bartonella quintana and Borrelia recurrentis. Primary- school children aged 6-12years are more at risk, although adults and children of other ages who have direct or indirect contact with primary-school children are also susceptible. The pattern and prevelance of pediculosis capitis is dependent on many sociodemographic and economic factors such as overcrowding, hair characteristics and poor hygiene. Lice infestation may lead to psychological distress and may disrupt learning performance of the children because of the social stigma associated with it.  An itching of the scalp is the chief symptom. Girls are 2 to 4 times more frequently infested than boys, especially in rural and developing areas owing to their hair length. Their was no consistent pattern of age distribution. sores on the scalp, neck and shoulders. scratching can lead to small, red bumps that may sometimes get infected with bacteria.  
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