CTRI

FULL DETAILS (Read-only) -> Click Here to Create PDF for Current Dataset of Trial

CTRI Number

CTRI/2024/12/077846 [Registered on: 09/12/2024] Trial Registered Prospectively

Last Modified On:

07/12/2024

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Homeopathy

Study Design

Single Arm Study

Public Title of Study

Role of Homoeopathic Medicines in Treatment of Generalised Anxiety Disorder

Scientific Title of Study

Utility of Homoeopathic Medical Repertory by Dr. Robin Murphy in management Of Generalized Anxiety Disorder in adult population - A prospective single arm, pre-post, clinical study

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
Not Applicable	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Diksha Verma
Designation	PG Scholar
Affiliation	Bakson Homoeopathic Medical College and Hospital
Address	Department of Repertory Bakson Homoeopathic Medical College and Hospital Plot no 36 B Knowledge park Phase 1 Greater Noida Gautam Buddha Nagar Uttar Pradesh Gautam Buddha Nagar UTTAR PRADESH 201310 India
Phone	9971408393
Fax
Email	dikshav42@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Shailja Upadhyay
Designation	Associate Professor
Affiliation	Bakson Homoeopathic Medical College and Hospital
Address	Department of Repertory Basement Room no B15 Bakson Homoeopathic Medical College and Hospital Plot no 36 B Knowledge park Phase 1 Greater Noida Gautam Buddha Nagar Uttar Pradesh Gautam Buddha Nagar UTTAR PRADESH 201310 India
Phone	8447753501
Fax
Email	drshailjaupadhyay22@gmail.com

Details of Contact Person
Public Query

Name	Dr Ashwini Nair
Designation	PG Incharge And HOD
Affiliation	Bakson Homoeopathic Medical College and Hospital
Address	Department of Materia Medica Second Floor Room No S2 Bakson Homoeopathic Medical College and Hospital Plot no 36 B Knowledge park Phase 1 Greater Noida Gautam Buddha Nagar Uttar Pradesh Gautam Buddha Nagar UTTAR PRADESH 201310 India
Phone	9990178024
Fax
Email	pginchargebakson@gmail.com

Source of Monetary or Material Support

Bakson Homoeopathic Medical College and Hospital 36 B Knowledge Park Phase 1 Greater Noida Gautam Budhha Nagar Uttar Pradesh 201310 India

Primary Sponsor

Name	Bakson Homoeopathic Medical College and Hospital
Address	Principal Office Room no G 22 Ground Floor Bakson Homoeopathic Medical College and Hospital 36 B Knowledge Park Phase 1 Greater Noida Gautam Buddha Nagar Uttar Pradesh 201310
Type of Sponsor	Private medical college

Details of Secondary Sponsor

Name	Address
NIL	Not Applicable

Countries of Recruitment

India

Sites of Study

No of Sites = 2
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Diksha Verma	Bakson Homoeopathic Medical College and Hospital	G 22 Ground Floor Bakson Homoeopathic Medical College and Hospital 36 B Knowledge Park Phase 1 Greater Noida Gautam Buddha Nagar Gautam Buddha Nagar UTTAR PRADESH	9971408393 dikshav42@gmail.com
Diksha Verma	Dr D P Rastogi Central Research Institute of Homoeopathy	Out Patient Department (OPD) Room No 110 Ground Floor A1/1 Sector 24 Noida Gautam Buddha Nagar Gautam Buddha Nagar UTTAR PRADESH	9971408393 dikshav42@gmail.com

Details of Ethics Committee

No of Ethics Committees= 2
Name of Committee	Approval Status
Baksons Institutional Ethics Committee	Approved
Kendriya Homoeopathy Anusandhan	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: F411\|\|Generalized anxiety disorder,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Homoeopathic Medicine	Pill form 30 pill size Oral route of administration Centisimal scale First dose at the time of case taking subsequent doses according to follow up upto atleast 6 months.
Comparator Agent	NIL	NIL

Inclusion Criteria

Age From	18.00 Year(s)
Age To	54.00 Year(s)
Gender	Both
Details	Participants fulfilling the DSM 5 diagnostic Criteria for GAD. Participants aged 18 years to 54 years. Participants of both sexes.

ExclusionCriteria

Details

Participating Women, those who are pregnant or in lactating phase.
Participants with known history of untreated or uncontrolled systemic disorders and immunocompromised state
Participants with severe psychiatric disorder, substance abuse.
Participants who are on homoeopathic treatment for any other disease condition.
Participants refusing to give consent

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Changes will be observed in Hamilton Anxiety Scale Changes can be positive negative or no change	Changes will be observed in Hamilton Anxiety Scale at interval of one month for 6 months. Changes can be positive negative or no change

Secondary Outcome

Outcome	TimePoints
NIL	Not Applicable

Target Sample Size

Total Sample Size="40"
Sample Size from India="40"
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)

18/12/2024

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="3"
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

This study will assess the usefullness of Homoeopathic Medical Repertory by Dr Robin Murphy in managing the cases of Generalised Anxiety Disorder

Prospective single arm pre post clinical study

Sample size is 40

Hamilton Anxiety scale will be used to assess the changes