| CTRI Number |
CTRI/2024/10/075957 [Registered on: 28/10/2024] Trial Registered Prospectively |
| Last Modified On: |
25/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study on effect of Homoeopathic Drug Curcuma Longa in endometriosis under
laboratory setting with clinical study of the same in endometriosis patients |
|
Scientific Title of Study
|
An in vitro study on the effectiveness of various potencies of Homoeopathic medicine Curcuma longa in decreasing the viability of endometriosis tissue and clinical verification -a randomized controlled 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 Geethu P |
| Designation |
Post graduate scholar |
| Affiliation |
Government Homoeopathic medical college Karaparamba Kozhikode |
| Address |
Department of Homoeopathic Repertory and Case taking Government Homoeopathic Medical College Karaparamba Kozhikode
Kozhikode
KERALA
673010
India |
| Phone |
9496365167 |
| Fax |
|
| Email |
drgeethunikhil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mansoor Ali K R |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
Government Homoeopathic medical college Karaparamba Kozhikode |
| Address |
Department of Homoeopathic Repertory and Case taking Government Homoeopathic Medical College Karaparamba Kozhikode
Kozhikode
KERALA
673010
India |
| Phone |
9249337799 |
| Fax |
|
| Email |
drmansoorkr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geethu P |
| Designation |
Post graduate scholar |
| Affiliation |
Government Homoeopathic medical college Karaparamba Kozhikode |
| Address |
Department of Homoeopathic Repertory and Case taking Government Homoeopathic Medical College Karaparamba Kozhikode
Kozhikode
KERALA
673010
India |
| Phone |
9496365167 |
| Fax |
|
| Email |
drgeethunikhil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gov Homoeopathic medical college Karapparamba Kozhikkode PIN - 673010 Kerala India |
|
|
Primary Sponsor
|
| Name |
Geethu P |
| Address |
Post graduate scholar Department of Homoeopathic Repertory and Case Taking Government Homoeopathic Medical college Karaparamba Kozhokode |
| 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 geethu P |
Government Homoeopathic medical college Karaparamba |
Gynaec department op room no 6 Gov Homoeopathic medical college Karapparamba Kozhikode 673010 Kerala India
Kozhikode
KERALA 9496365167
drgeethunikhil@gmail.com
Kozhikode
KERALA |
9496365167
drgeethunikhil@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: N809||Endometriosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Curcuma longa |
Curcoma longa30 or 12C in 40 size globule 4 globule two times daily for 2 weeks |
| Comparator Agent |
Homoeopathic constitutional medicine |
Homoeopathic Constitutional medicine according to Homoeopathic principles |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1 Patients with symptoms and signs of endometriosis
2 Female, 18years to 60years old
3 Cases fulfilling the examination findings and transvaginal USG finding. |
|
| ExclusionCriteria |
| Details |
1 Complicated endometriosis cases requiring surgery
2 Endometriosis cases with severe bleeding and Hb less than 8
3 Cases with psychiatric illness
4 Any active malignancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
CLINICAL STUDY
TITLE - Changes in the endometriosis health profile questionnaire (EHP-5)
before and after treatment, every 4 weeks.
DESCRIPTION - Baseline EHP 5 questionnaire score – Final EHP
5questionnaire score
Interval:3 months |
TITLE - Changes in the endometriosis health profile questionnaire (EHP-5)
after 12 weeks of treatments
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of therapeutic effectiveness of Curcuma longa and Homoeopathic constitutional medicine among the group |
after 1 year(after completion of study) |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
06/11/2024 |
| 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 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
|
Study is an In vivo evaluation of the effect of Homoeopathic medicne Curcuma longa and constitutional medicine in patients with endometriosis RCT.There are two groups , one will recieve Curcuma longa and second group will recieve constitutional medicine by randimization.Diagnosis of the case will be based on the EHP 5 questionnaire score before and after the study. |