| CTRI Number |
CTRI/2024/06/068469 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
30/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
To see the effectiveness of homoeopathic medicine in cases of psychosomatic disorders |
|
Scientific Title of Study
|
Miasmatic interpretation of psychosomatic disorders with its homoeopathic management |
| 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 AISHVARIYA A PATHAK |
| Designation |
PG scholar |
| Affiliation |
Rajkot Homoeopathic medical College |
| Address |
Department of Organon of medicine and homeopathic philosophy, Rajkot Homoeopathic Medical College, Behind jainath complex, Makkam chowk, Gondal road, Rajkot
Rajkot
GUJARAT
360002
India |
| Phone |
9925846960 |
| Fax |
|
| Email |
210409202003@paruluniversity.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr mital kacha |
| Designation |
Assistant professor |
| Affiliation |
Rajkot Homoeopathic medical College |
| Address |
Department of organon of medicine and homoeopathic philosophy, Rajkot Homoeopathic medical College, behind jainath complex, makkam chowk, Gondal road, Rajkot
Rajkot
GUJARAT
360002
India |
| Phone |
9687459141 |
| Fax |
|
| Email |
dr.mitalkacha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR AISHVARIYA PATHAK |
| Designation |
PG scholar |
| Affiliation |
Rajkot Homoeopathic medical College |
| Address |
Department of Organon of medicine and homeopathic philosophy, Rajkot Homoeopathic Medical College, Behind jainath complex, Makkam chowk, Gondal road, Rajkot
Rajkot
GUJARAT
360002
India |
| Phone |
9925846960 |
| Fax |
|
| Email |
210409202003@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Rajkot Homoeopathic medical College |
|
|
Primary Sponsor
|
| Name |
Rajkot Homoeopathic medical College |
| Address |
Behind jainath complex, makkam chowk, Gondal road, Rajkot |
| 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 AISHVARIYA PATHAK |
Sainath homoeopathic hospital attached with Rajkot Homoeopathic medical College |
Behind jainath complex, makkam chowk, Gondal road, Rajkot -360002, Gujarat, India
Rajkot
GUJARAT |
9925846960
210409202003@paruluniversity.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for human research -Rajkot homoeopathic medical College (RHMC), Parul University, Gujarat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised homoeopathic medicine |
Individualised homoeopathic medicine selected by considering miasm. Selection of potency, doses and repertition is done according to susceptibility of patients and principles. of organon of medicine . 30, 200 and 1m potencies will be given to the patients. Route of administration will be oral sublingual way. The study will continue for 9 months |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Cases of all gender are included
Age group 18to 65
Patient irrespective of socio economic status , occupation will be consider .
|
|
| ExclusionCriteria |
| Details |
Purely surgical cases
Emergency &accidental cases
Patient in critical care
Immune compromised patients
Patient with irreversible pathological changes |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patients of psychosomatic diseases will be benefited by individualised homoeopathic medicine |
Patients of psychosomatic diseases will be benefited by individualised homoeopathic medicine . This outcomes will be achieved in the period of 9 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 significant improvement _disapperance of all signs & symptoms with no relapse for 6 month
2 moderate improvement _decrease in intensity & /or frequency of presenting complaints with feelings of well being.
Status quo : Neither increase nor decrease in the symptoms of the patients |
1 significant improvement _disapperance of all signs & symptoms with no relapse for 6 month
2 moderate improvement _decrease in intensity & /or frequency of presenting complaints with feelings of well being.
Status quo : Neither increase nor decrease in the symptoms of the patients . All these goals will be achieved in the period of 9 months |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
13/06/2024 |
| 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)
|
Not Yet Recruiting |
| 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
|
Psychosomatic disorder, also called Psychophysiologic
Disorder, condition in which psychological stresses adversely af￾fect physiological (somatic) functioning to the point of distress.It is a condition of dysfunction or structural damage in bod￾ily organs through inappropriate activation of the involuntary
nervous system and the glands of internal secretion. Thus, the
psychosomatic symptom emerges as a physiological concomitant
of an emotional state.Psychosomatic disorders resulting from stress may include
hypertension, respiratory ailments, gastrointestinal disturbances,
migraine and tension headaches, pelvic pain, impotence, frigidity,
dermatitis, and ulcers.Prevalence rate of psychosomatic disorder are 21.5% of
psychiatric patients had psychosomatic illnesses. Fifty five cases
had two psychosomatic illnesses. Chronic pain (14.4%) and hy￾pertension (9.9%) were the commonest. Patients with psychoso￾matic disorders were significantly more often older in age, fe￾males, married and from an urban habitat.Hence, I want to conduct a study on Psychosomatic disor￾ders to treat with Homoeopathic medicine with usage of organon
of medicine, material medica and repertory as a tool to find out a
group of Homoeopathic medicines & finding most similar medi￾cine as per Homoeopathic Principles. |