| CTRI Number |
CTRI/2024/02/063237 [Registered on: 28/02/2024] Trial Registered Prospectively |
| Last Modified On: |
27/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy of Bellis perennis 200c in severity of dysmenorrhoea and prostaglandin e2 level in women with endometriosis |
|
Scientific Title of Study
|
Efficacy of Bellis perennis 200c in severity of dysmenorrhoea and prostaglandin e2 level in women with endometriosis |
| 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 Aswathy R K |
| Designation |
PG Scholar |
| Affiliation |
Sarada Krishna homoeopathic medical college |
| Address |
Department of Practice of Medicine
Sarada Krishna homoeopathic medical college Kulasekharam
Department of Practice of Medicine
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9497081167 |
| Fax |
0465279448 |
| Email |
draswathyrk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N V Sugathan |
| Designation |
principal and professor |
| Affiliation |
Sarada Krishna homoeopathic medical college |
| Address |
Department of Practice of Medicine
Sarada Krishna homoeopathic medical college Kulasekharam
Department of Practice of Medicine
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9443558786 |
| Fax |
0465279448 |
| Email |
drnvsugathan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aswathy R K |
| Designation |
PG Scholar |
| Affiliation |
Sarada Krishna homoeopathic medical college |
| Address |
Department of Practice of Medicine
Sarada Krishna homoeopathic medical college Kulasekharam
Department of Practice of Medicine
TAMIL NADU
629161
India |
| Phone |
9497081167 |
| Fax |
0465279448 |
| Email |
draswathyrk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sarada KRishna homoeopathic medical college |
|
|
Primary Sponsor
|
| Name |
Sarada Krishna Homoeopathic medical college |
| Address |
Sarada Krishna homoeopathic medical college Kulasekharam
Kanniyakumari |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sarada Krishna Homoeopathic medical college |
Sarada Krishna homoeopathic medical college Kulasekharam
Kanniyakumari |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Aswathy R K |
Sarada Krishna homoeopathic medical collegeand hospital |
Department of Practice of medicine
Kulasekharam
kanniyakumari
Kanniyakumari
TAMIL NADU |
9497081167
0465279448
draswathyrk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sarada Krishna homoeopathic medical college Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N736||Female pelvic peritoneal adhesions(postinfective), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Reproductive age group
Patient who are willing to do prostaglandin E2 in laboratory investigation
Severe dysmenorrhea in endometriosis.
Improve the quality of life |
|
| ExclusionCriteria |
| Details |
Patient with purely surgical correction, severe adhesions in endometriosis.
Patient who are not willing to do prostaglandin E2 in laboratory investigation
Known case of allergies in prostaglandin test
Known cases of pathologically advanced systemic diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The severity of dysmenorrhoea and the other symptoms of endometriosis improved with Bellis perinnis 200 C |
initial prescription and then after 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The severity of dysmenorrhoea & the other symptoms of endometriosis improved with Bellis perinnis 200 C |
first prescription then assess through laboratory investigation |
|
|
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)
|
10/03/2024 |
| 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="0"
Months="6"
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
|
Women with endometriosis suffer from symptoms such as chronic pelvic pain,dysmenorrhea and dyspareunia, which significantly reduce the quality of life.Dysmenorrhea is defined as pelvic pain around the time of menstruation. The painful cramps associated with menstrual cycles experienced by many women are thought to be prostaglandin (PG) related Their hypothesis was based on the finding that dysmenorrheic women had a higher concentration of PGF2, in menstrual fluid than did normal women . The aim of my study is to To describe the efficacy of BELLIS PERENNIS 200 C in improving the severity of dysmenorrhea and prostaglandinE2 production in women with endometriosis.The pre and post assessment is done using Prostaglandin E2 level in blood .
|