| CTRI Number |
CTRI/2025/06/088914 [Registered on: 16/06/2025] Trial Registered Prospectively |
| Last Modified On: |
13/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Series |
| Study Design |
Other |
|
Public Title of Study
|
Study on Anxiety evolution and expression in Children Treated with Calcarea Remedies using SCAS Questionnaire |
|
Scientific Title of Study
|
Comparing the evolution and expression of anxiety assessed with spence children anxiety scale (SCAS) in paediatric patients prescribed Calcarea group of remedies : A prospective case series study |
| 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 Thamarai Ravishankar |
| Designation |
M D Resident Part I |
| Affiliation |
Dr. M. L. DHAWALE MEMORIAL HOMOEOPATHIC INSTITUTE |
| Address |
DR M L DHAWALE MEMORIAL HOMEOPATHIC INSTITUTE.
WORKSHOP BOISAR PALGHAR ROAD, PALGHAR TALUKA INDUSTRIAL COOPERATIVE ESTATE PALGHAR
Palghar – Boisar Road, Opp. S.T. Workshop, Palghar-401 404, Dist. Palghar, Maharashtra, India
Thane
MAHARASHTRA
401404
India |
| Phone |
7358456405 |
| Fax |
|
| Email |
thisisthamarai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandrasekhar Goda |
| Designation |
HEAD OF THE DEPARTMENT |
| Affiliation |
Dr. M. L. DHAWALE MEMORIAL HOMOEOPATHIC INSTITUTE |
| Address |
Dr M L Dhawale Memorial Homoeopathic Institute, Palghar Boisar Road, Opp. Municipal Corporation and Fire Brigade, Palghar 401 404, Dist. Palghar, Maharashtra, India
Thane
MAHARASHTRA
401404
India |
| Phone |
9322882918 |
| Fax |
|
| Email |
sujchan18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandrasekhar Goda |
| Designation |
HEAD OF THE DEPARTMENT |
| Affiliation |
Dr. M. L. DHAWALE MEMORIAL HOMOEOPATHIC INSTITUTE |
| Address |
Dr M L Dhawale Memorial Homoeopathic Institute, Palghar Boisar Road, Opp. Municipal Corporation and Fire Brigade, Palghar 401 404, Dist. Palghar, Maharashtra, India
Thane
MAHARASHTRA
401404
India |
| Phone |
9322882918 |
| Fax |
|
| Email |
sujchan18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr M L Dhawale Memorial Homoeopathic Institute, Palghar Palghar – Boisar Road, Opp. Municipal Corporation And Fire Brigade, Palghar-401 404, Dist. Palghar, Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
Dr M L Dhawale Memorial Homeopathic Institute, Palghar |
| Address |
Dr M L Dhawale Memorial Homoeopathic Institute, Palghar Boisar Road, Opp. Municipal Corporation and Fire Brigade, Palghar 401 404, Dist. Palghar, Maharashtra, India |
| Type of Sponsor |
Private medical college |
|
|
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 Chandrasekhar Goda |
Dr M L Dhawale Memorial Homeopathic Institute, Palghar |
Room number 306
Department of paediatrics
Dr M L Dhawale Memorial Homoeopathic Institute.
Thane
MAHARASHTRA |
9322882918
sujchan18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr M L Dhawale Memorial Homoeopathic Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F59||Unspecified behavioral syndromes associated with physiological disturbances and physical factors, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
1. Age Range 7 to 17 years of age.
2. Treatment Children who have received treatment with the above calcarea
group of remedies
3. Children whose T score is less than or equal to 65(showing signs of normal to
elevated levels of anxiety but not necessarily in clinical range) according to
spence children anxiety scale SCAS.
4. Children whose overall improvement is assessed using MONARCH Modified
Naranjo Criteria for Homeopathy scale.
5. Cases in which parents will give assent for their child. |
|
| ExclusionCriteria |
| Details |
1. Children who are diagnosed with anxiety disorders. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the evolutionary patterns and expressions of anxiety assessed
using SCAS (Spence children’s anxiety scale) in children prescribed
calcarea group of remedies. |
SCAS 0 weeks during screening
MONARCH 3 months used to assess overall improvement |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="27"
Sample Size from India="27"
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)
|
24/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/06/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
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
|
A study on how anxiety evolves in a child and how it expresses in children taking calcarea group of remedies and observing the changes in anxiety using spence children anxiety scale We will select children from ages 7 to 17 and then compare how anxiety evolves and expressed in them First we will use Spence children anxiety scale and understand which calcarea group of remedies he belongs to. If he falls under it then we will prescribe the medicine and understand how anxiety evolves and expresses in him. |