| CTRI Number |
CTRI/2022/06/043100 [Registered on: 08/06/2022] Trial Registered Prospectively |
| Last Modified On: |
15/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The Study To assess The Effectiveness Of Homoeopathic Medicine Viburnum Opulus In Cases Of Pelvic Inflammatory Disease In Comparison To Individualized Medicines. |
|
Scientific Title of Study
|
A Randomized Controlled Trial To Assess The Effectiveness Of Individualized Medicine As Compared To Individualized Medicine Along With Viburnum Opulus As An Add On Therapy In The Management Of Pelvic Inflammatory Disease |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ankita Srivastava |
| Designation |
PG Student |
| Affiliation |
Dr MPK Homoeopathic Medical College Hospital And Research Centre Homoeopathy University |
| Address |
Dr MPK Homoeopathic Medical College Hospital And Research Centre Saipura Sanganer Jaipur
Saipura Sanganer Jaipur Pin Code 302029
Jaipur
RAJASTHAN
302029
India |
| Phone |
8503039881 |
| Fax |
|
| Email |
ankitasri229@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vanija Sharma |
| Designation |
Associate Professor |
| Affiliation |
Dr MPK Homoeopathic Medical College Hospital And Research Centre Homoeopathy University |
| Address |
Dr MPK Homoeopathic Medical College Hospital And Research Centre Saipura Sanganer Jaipur
Saipura Sanganer Jaipur Pin Code 302029
Jaipur
RAJASTHAN
302029
India |
| Phone |
9680438770 |
| Fax |
|
| Email |
drvanijasharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankita Srivastava |
| Designation |
PG Student |
| Affiliation |
Dr MPK Homoeopathic Medical College Hospital And Research Centre Homoeopathy University |
| Address |
Dr MPK Homoeopathic Medical College Hospital And Research Centre Saipura Sanganer Jaipur
Saipura Sanganer Jaipur Pin Code 302029
Jaipur
RAJASTHAN
302029
India |
| Phone |
8503039881 |
| Fax |
|
| Email |
ankitasri229@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Girendra Pal Homoeopathic Hospital and Research Centre Collegiate Hospital Of Homoeopathy University Jaipur |
|
|
Primary Sponsor
|
| Name |
Dr MPK Homoeopathic Medical College Hospital and Research Centre |
| Address |
Saipura Sanganer Jaipur Rajasthan Pin Code 302029 |
| 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 Ankita Srivastava |
Dr Girendra Pal Homoeopathic Hospital and Research Centre |
Department Of Materia Medica, Unit 1,Room Number 4
Jaipur
RAJASTHAN |
8503039881
ankitasri229@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicines |
According to symptoms similarity 200ch or 1M 1dose or 2 dose 4 globules for 14 days according to patients susceptibility |
| Comparator Agent |
Individualized Homoeopathic Medicines along with viburnum opulus |
Individualized Homoeopathic Medicines-According to symptoms similarity 200ch or 1M 1dose or 2 dose 4 globules for 14 days according to patients susceptibility.
Viburnum Opulus-1.Leucorrhoea: thick, white, and copious; thin, yellowish white after menses.
2.Pain in ovarian region. 3.Bearing-down pains: in pelvic region,with uneasiness.
4.Menstrual pain.
5.Menses began ten days early (always regular before)
6.pain in back and cramps lasted throughout the period, Dysmenorrhoea.
8.Cramps in the calves always between the menses, just before the period.
9.scanty, delayed menstruation, &etc
30 tds 2 globules for 14days
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Previously diagnosed cases of PID seeking homoeopathic treatment or newly diagnosed.
2. As per sign & symptoms and CDC (adopted from DC Dutta’s textbook of gynecology 7th edition) Patients with 3-4 confirmatory sign and symptoms given below shall be enrolled for the study irrespective of the diagnosis based on investigations-
a. Pelvic pain or lower abdomen pain or back pain.
b. Abnormal & heavy Vaginal discharge (purulent and or copious)
c. Offensive vaginal odor.
d. Cervical motion tenderness.
e. Lower abdomen tenderness.
f. Adnexal tenderness.
g. Pruritis vulva.
h. Burning.
i. Dyspareunia.
j. Irregular vaginal bleeding.
k. Fever
Diagnostic criteria-
1.symptoms as mentioned above.
2.USG/ laboratory investigation done if required in case of unclear symptoms given above.
|
|
| ExclusionCriteria |
| Details |
1. Cases which required any emergency treatment.
2. Patient pursuing other treatment and were not willing to leave it.
3. Pregnant women and lactating mothers will not be included in the study.
4.Immunocompromised patient such as suffering from HIV, Hepatitis B/C etc.
5.Cases with multi systemic illness will be excluded from the study and cases with advance pathology & malignancy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in VAS score will be noted for every symptom before, during and after treatment and shall be analysed to assess the efficacy of treatment given. |
Changes in VAS score will be noted for every symptom before, during and after treatment and shall be analysed to assess the efficacy of treatment given at 12 month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in WHO QOL-BREF scale will be noted for before and after treatment and shall be analysed to assess the efficacy of treatment given . |
1year |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/06/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A Study is A randomized controlled trial to assess the effectiveness of individualized medicine as compare individualized medicine Viburnum opulus as an add on therapy in the management of pelvic inflammatory disease. Study will be done on 70 patients carried out for 12 months. The out come assessment will be done on the basis of Changes in VAS score will be noted for every symptom and WHO QOL-BREF before and after treatment. |