| CTRI Number |
CTRI/2025/03/081504 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
homoeopathic individualized medicine in management of PID using murphys repertory |
|
Scientific Title of Study
|
A Clinical Utility Of Homoeopathic Medical Repertory By Robin Murphy In Management Of Pelvic Inflammatory Disease |
| 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 Amita Soni |
| Designation |
Postgraduate Trainee |
| Affiliation |
State National Homoeopathic Medical College and Hospital Viraj khand 1 Gomti Nagar Lucknow |
| Address |
Department Of Case Taking And Homoeopathic Repertory
State National Homoeopathic Medical College And Hospital Viraj Khand 1 Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
7906106624 |
| Fax |
|
| Email |
amitasoni71135@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjani kumar singh |
| Designation |
Asst Professor |
| Affiliation |
State National Homoeopathic Medical College and Hospital Viraj khand 1 Gomti Nagar Lucknow |
| Address |
Department Of Practice Of Medicine
State National Homoeopathic Medical College and Hospital Viraj khand 1 Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9918875566 |
| Fax |
|
| Email |
nhmcanjani1985@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amita Soni |
| Designation |
Postgraduate Trainee |
| Affiliation |
State National Homoeopathic Medical College and Hospital Viraj khand 1 Gomti Nagar Lucknow |
| Address |
Department Of Case Taking And Homoeopathic Repertory
State National Homoeopathic Medical College And Hospital Viraj Khand 1 Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
7906106624 |
| Fax |
|
| Email |
amitasoni71135@gmail.com |
|
|
Source of Monetary or Material Support
|
| Out Patient And Inpatient Department Of State National Homoeopathic Medical College And Hospital Viraj Khand 1 Gomtinagar Lucknow UP |
|
|
Primary Sponsor
|
| Name |
Dr Amita Soni |
| Address |
State National Homoeopathic Medical College And Hospital Viraj Khand 1 Gomtinagar Lucknow UP |
| 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 Amita Soni |
State National Homoeopathic Medical College And Hospital Lucknow Uttar Pradesh |
OPD 6 Department of Case Taking And Homoeopathic Repertory State National Medical College And Hospital Viraj Khand 1 Gomtinagar Lucknow 226010 UP
Lucknow
UTTAR PRADESH |
7906106624
amitasoni71135@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of State National Homoeopathic Medical College And Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N739||Female pelvic inflammatory disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
Patients qualifying to inclusion criteria will be included in the study. Proper case taking of all enrolled patients will be done in standardized case taking proforma which is being used in State National Homoeopathic medical college and hospital. Homoeopathic medicines will be prescribed to all patients after analysis and evaluation of symptoms and proper repertorization using Homoeopathic Medical Repertory by Robin Murphy.Indicated homoeopathic remedy will be administered as decided appropriate to the case or condition in appropriate potency and doses. Medicines will be given oral route. Each case will be followed up at regular interval preferably at a period of 15 days or as per requirement. Patient will be studied for 6 months after enrolment in study. Outcome assessment of the patients will be carried out after 6 months of homoeopathic medication based on improvement in symptoms and quality of life using ORIDL(OUTCOME RELATED TO IMPACT ON DAILY LIVING) scale and pain assessment using VAS(VISUAL ANALOGUE SCALE)scale |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1 Female of reproductive age group
2 Diagnosed cases of PID postulate homoeopathic treatment
3 According to the CDCs sign and symptoms
guidelines adapted from DC
Duttas seventh edition textbook on gynecology
patients who present three to four of the
following confirmed signs and symptoms will be
included in the study
a Lower abdominal and pelvic pain or tenderness
b Abnormal vaginal discharges
c Dyspareunia
d Irregular vaginal bleeding
e Fever
f Nausea and Vomiting
g Cervical motion tenderness on bimanual
examination
4 Patient giving consent to participate
5 A past record of engaging with multiple partners
or participating in unprotected intercourse |
|
| ExclusionCriteria |
| Details |
1 Patients who are not willing to give their
consent for the study and complying regular
follow up
2 Patient suffering from psychiatric diseases
3 Chronic systemic illness example Epilepsy
Cardiovascular Renal and Endocrinal disorders etc
Patient with advance pathology pelvic
peritonitis Septicemia etc and malignancies
4 Use of medications Antidepressants anticonvulsive
medications and refuse to stop
5 Pregnant women and nursing mothers
6 immunocompromised patients such as those with HIV
Hepatitis B and C etc |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the role of individualized Homoeopathic medicine in the management of pelvic inflammatory disease |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Application of Homoeopathic medical repertory by Robin Murphy in the management of pelvic inflammatory disease |
6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
10/03/2025 |
| 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
|
Pelvic Inflammatory Disease (PID) refers to the infection and inflammation of the female reproductive organs, including the uterus, fallopian tubes, ovaries, and surrounding tissue. Inflammation travels to the upper genital tract from the cervix or vagina .The incidence among women who are sexually active ranges from 1% to 2% annually. In females of reproductive age who are sexually active over 85% of infections are spontaneous .Pelvic Inflammatory Disease PID research is essential for expanding our knowledge of medicine enhancing clinical results and creating preventative measures.Conventional medicinal treatment for pelvic inflammatory disease (PID) often involves using a combination of antibiotics to combat different bacteria.However extended use of these medications may result in serious side effects including damage to the bodys natural bacterial balance kidney failure liver failure and other complications.In homoeopathy more importance is given to the diseased individual than disease itself thereby improving the health of the patient both mentally and clinically.Thus homoeopathic medicine can definitely render immense benefit in cases of pelvic inflammatory disease when employed logically and judicially with the fabric of homoeopathy.With the help of Homoeopathic medical repertory we can find out the similimum on the basis of clinical as well as classical symptoms. This repertory merges both kind of practice unlike many other repertories and it has the Advantage of meeting the requirement of various types of cases. The results of this study will provide information that may justify treatment of patients suffering from PID by Homoeopathic medicne which is more cost effective and devoid of any adverse drug reactions. |