| CTRI Number |
CTRI/2025/04/084271 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
12/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of homoeopathic medicine Lycopodium clavatum in reducing symptoms of ADHD in children |
|
Scientific Title of Study
|
Effectiveness of Lycopodium Clavatum on symptoms of Attention Deficit Hyperactive Disorder among children of age group 6 to 12 years |
| 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 Nisha M |
| Designation |
Professor |
| Affiliation |
Govt Homoeopathic Medical college, Thiruvananthapuram |
| Address |
Department of Materia medica, Govt Homoeopathic Medical College, Thiruvananthapuram
Thiruvananthapuram
KERALA
695009
India |
| Phone |
9846319984 |
| Fax |
|
| Email |
nisha_nizam@yahoo.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Susy Charles |
| Designation |
Professor |
| Affiliation |
Kerala University of Health Sciences |
| Address |
Department of Materia medica, Dr Padiyar Memorial Homoeopathic Medical College, Chottanikkara, Ernakulam
Chinganthara House, , SNRA - 55,Sahrudaya Nagar, Edapally P.O, Cochin - 24
Ernakulam
KERALA
682312
India |
| Phone |
9447575888 |
| Fax |
|
| Email |
drsusycharles@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nisha M |
| Designation |
Professor |
| Affiliation |
Govt Homoeopathic Medical college, Thiruvananthapuram |
| Address |
Department of Materia medica, Govt Homoeopathic Medical College, Thiruvananthapuram
Thiruvananthapuram
KERALA
695009
India |
| Phone |
9846319984 |
| Fax |
|
| Email |
nisha_nizam@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Govt Homoeopathic Medical College, Thiruvananthapuram, Kerala. 695009 |
|
|
Primary Sponsor
|
| Name |
Dr Nisha M |
| Address |
Department of Materia medica, Govt Homoeopathic Medical College, Thiruvananthapuram.Kerala 695009
695009. India |
| Type of Sponsor |
Other [Self] |
|
|
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 Nisha M |
Govt Homoeopathic Medical College |
Department of Materia medica,OPD foe Paediatric neurodevelopmental disorders , manacaud P O, Iranimuttom, Trivandrum 695009
Thiruvananthapuram
KERALA |
09846319984
nisha_nizam@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| instituitional Ethics Committee, Govt Homoeopathic Medical College, Thiruvananthapuram |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
individualised homoeopathic medicines |
cases will be subjected to detailed case taking and repertorisation using kents repertory. From the list of medicines obtained, the most appropriate similimum will be selected consulting Materia medica. The medicines will be selected as per case and will be administered in proper dose and potency. 3 pills of No 40 size in sugar of milk will be administered orally.Each case will be reviewed every two weeks, symptoms will be recorded and medicine will be repeated if necessary. Cases will be reviewed for a period of six months |
| Intervention |
Lycopodim clavatum |
Lycopodium clavatum will be administered in proper dose and potencies according to homoeopathic principles in each case. Lycopodium clavataum will be administered orally as 3 pills of no 40 size in sugar of milk as first prescription. Cases will be reviewed and symptoms will be recorded every 2 weeks and medicine will be repeated if necessary. Each case will be reviewed for a period of six months |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Cases satisfying the diagnostic criteria for attention
deficit hyperactivity disorder as per DSM- V.
|
|
| ExclusionCriteria |
| Details |
1. Cases with severe systemic illness
2. Morbid psychiatric disorders
3. Patients receiving Attention Deficit Hyperactive Disorder medications.
4. Patients having other behavioural disorders like oppositional behavioural disorder and conduct disorder.
5. Parents of children who are not willing to give consent (written)
6. Children who are not willing to give assent(verbal)
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to study the effectiveness of Lycopodium clavatum in symptoms of ADHD |
Outcome will be assessed based on Conner’s Parent rating scale -Revised (S) scores at the beginning and end of six months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to study the effectiveness of constitutional medicines in managing symptoms of ADHD and to find out which is the most frequently indicated medicine |
assessed at the beginning and end of six months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/05/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Background: Attention Deficit Hyperactive Disorder is a common childhood behavioural condition characterised by persistent symptoms of inattention, hyperactivity and impulsivity which is inappropriate for the age.Objectives: To compare the effectiveness of Lycopodium clavatum versus individualised homoeopathic remedies in the treatment outcome among children in the age group of 6 to 12 years as measured by Conner’s Parent Rating scale – Revised (S). Materials and Methods: A Randomised control study is proposed to be conducted at Govt Homoeopathic Medical College, Thiruvananthapuram. Interventions: Cases will be grouped into two arms, experimental group will be administered Lycopodium clavatum and control group will be administered individualised homoeopathic medicines in proper dose and potency. Outcome measures: Conner’s Parent Rating Scale – Revised(S) Conclusion: The present study aims to obtain a positive outcome in the management of Attention Deficit Hyperactive Disorder using Lycopodium clavatum |