CTRI

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CTRI Number

CTRI/2025/03/082051 [Registered on: 10/03/2025] Trial Registered Prospectively

Last Modified On:

07/03/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Homeopathy

Study Design

Single Arm Study

Public Title of Study

Effectiveness of homoeopathic medicine in management of ganglion cyst of hand

Scientific Title of Study

Role of individualized homoeopathic medicine in 50 millesimal scale in management of ganglion cyst of hand and open single arm pre and post clinical trial

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 Diksha Bhardwaj
Designation	Post graduate trainee
Affiliation	National Institute of Homoeopathy
Address	OPD no 14 Organon of medicine National Institute of Homoeopathy GE block Sector III Salt Lake Kolkata 700106 West Bengal OPD no 14 Organon of medicine National Institute of Homoeopathy GE block Sector III Salt Lake Kolkata 700106 West Bengal Kolkata WEST BENGAL 700106 India
Phone	7292000725
Fax
Email	dr.dikshabhardwaj612@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Diksha Bhardwaj
Designation	Post graduate trainee
Affiliation	National Institute of Homoeopathy
Address	OPD no 14 Organon of medicine National Institute of Homoeopathy GE block Sector III Salt Lake Kolkata 700106 West Bengal OPD no 14 Organon of medicine National Institute of Homoeopathy GE block Sector III Salt Lake Kolkata 700106 West Bengal Kolkata WEST BENGAL 700106 India
Phone	7292000725
Fax
Email	dr.dikshabhardwaj612@gmail.com

Details of Contact Person
Public Query

Name	Dr Gobind Narayan Gupta
Designation	Associate professor
Affiliation	National Institute of Homoeopathy
Address	OPD no 14 Organon of medicine National Institute of Homoeopathy GE block Sector III Salt Lake Kolkata 700106 West Bengal OPD no 14 Organon of medicine National Institute of Homoeopathy GE block Sector III Salt Lake Kolkata 700106 West Bengal Kolkata WEST BENGAL 700106 India
Phone	9163197805
Fax
Email	dr.gn05gupta@gmail.com

Source of Monetary or Material Support

NIL

Primary Sponsor

Name	National Institute Of Homoeopathy
Address	National Institute of Homoeopathy GE block Sector III Salt Lake Kolkata 700106 West Bengal
Type of Sponsor	Government 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 Diksha Bhardwaj	National Institute Of Homoeopathy	OPD no 14 Organon of medicine National Institute of Homoeopathy GE block Sector III Salt Lake Kolkata 700106 West Bengal Kolkata WEST BENGAL	07292000725 dr.dikshabhardwaj612@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
National Institute Of Homoeopathy	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: M674\|\|Ganglion,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Individualized Homoeopathic Medicine in fifty millesimal scale	Detailed and thorough case taking of each and every patient suffering from Ganglion cyst of hand shall be done in accordance with the direction laid down by Dr C F S Hahnemann in the Organon of Medicine from §83 to §104 Indicated Homoeopathic medicines in Fifty Millesimal potencies will be given as per the requirement and direction of Hahnemann from National Institute of Homoeopathy dispensary as selected appropriate to the case or condition according to the symptom totality based on §153 that is Striking Singular Uncommon and Peculiar (Characteristics) Signs and Symptoms Dose and repetition will be according to the case Follow up will be done on the regular basis or as per need of the cases up to 6 months and total duration of study for 18 months
Comparator Agent	NIL	NIL

Inclusion Criteria

Age From	5.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	1. Diagnosed and stable patient suffering from Ganglion cyst of hand. 2. Age 5-65 years. 3. All sexes. 4. Ability to read Bengali or Hindi or English or understand any. 5. Providing written informed consents/assent form.

ExclusionCriteria

Details

1. Cases require any immediate surgical intervention or life support measures for any
other pathology.
2. Cases suffering from uncontrolled systemic illness or life-threatening infections.
3. Unwilling to take part and not giving consent to join the study.
4. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life
threatening illness affecting quality of life or any organ failure.
5. Pregnant women and lactating mothers
6. Substance abuse and/or dependence.
7. Self-reported immune-compromised state, and
8. Undergoing homoeopathic treatment for any chronic disease within last 3 months.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
The outcome assessment of the patients shall be calculated as per changes in and applying the core interpretation of Patient Rated Hand/ Wrist Evaluation (PRHWE) Score, Visual analogue scale (VAS) and Modified Naranjo Criteria.	At baseline and 6 months

Secondary Outcome

Outcome	TimePoints
NIL	NIL

Target Sample Size

Total Sample Size="50"
Sample Size from India="50"
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)

20/03/2025

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="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

This prospective, open-label, single-arm pre-post clinical trial will be conducted over 18 months at the National Institute of Homoeopathy, Kolkata, with each patient followed for six months. The study aims to evaluate the effectiveness of individualized homoeopathic medicine in management of ganglion cyst of hand. This study aims to assess changes in Ganglion cysts of the hand using the Patient-Rated Wrist/Hand Evaluation Score and pain levels via the Visual Analogue Scale (VAS). It also evaluates overall well-being through the Modified Naranjo Criteria, determines the prevalence of Ganglion cysts based on age, sex, socio-economic status, and occupation among NIH OPD/IPD patients, and identifies the most frequently indicated homoeopathic medicines along with their miasmatic background for effective management. Adults aged 05-65 years suffering from ganglion cysts of hand, fluent in English, Hindi, or Bengali, and willing to provide consent will be included. Exclusion criteria include cases requiring immediate surgery or life support, those with uncontrolled systemic illness, life-threatening infections, or organ failure, unstable psychiatric conditions, pregnant or lactating women, substance abuse or dependence, self-reported immunocompromised state, and patients under homeopathic treatment for chronic disease within the last three months or unwilling to give consent. Individualized homeopathic remedies will be selected based on repertorization (RADAR OPUS) and Materia Medica, following Hahnemannian principles, with monthly follow-ups for six months to assess symptom changes. The outcome assessment of the patients shall be calculated as per changes in and applying the core interpretation of Patient Rated Hand/ Wrist Evaluation (PRHWE) Score, Visual analogue scale (VAS) and Modified Naranjo Criteria at baseline and after 6 months.