| CTRI Number |
CTRI/2022/04/041604 [Registered on: 04/04/2022] Trial Registered Prospectively |
| Last Modified On: |
01/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
effectiveness of homoeopathic medicine in management of premenstrual symptoms |
|
Scientific Title of Study
|
Clinical study on premenstrual syndrome with homoeopathic management by using synthesis-repertorium homeopathicum syntheticum 9.1 repertory |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rafiya A |
| Designation |
PG Scholar |
| Affiliation |
Vinayaka Missions homoeopathic medical college and Hospital |
| Address |
Department of repertory opd room no 2C
Vinayaka Missions homoeopathic medical college and
Hospital nh 47 sankari main road seeragapadi salem
Tamilnadu
Salem
TAMIL NADU
636308
India |
| Phone |
9597065625 |
| Fax |
|
| Email |
dr.rafiyabhms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr J Senthilkumar |
| Designation |
Professor and Head of Department |
| Affiliation |
Vinayaka Missions homoeopathic medical college and Hospital |
| Address |
Department of repertory
opd room no 3c
Vinayaka Missions homoeopathic medical college and Hospital NH 47 sankari main road seeragapadi
Salem
Tamilnadu
Salem
TAMIL NADU
636308
India |
| Phone |
9842780556 |
| Fax |
|
| Email |
drjsenthil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr J Senthilkumar |
| Designation |
Professor and Head of Department |
| Affiliation |
Vinayaka Missions homoeopathic medical college and Hospital |
| Address |
Department of repertory
opd room no 3c
Vinayaka Missions homoeopathic medical college and Hospital NH 47 sankari main road seeragapadi
Salem
Tamilnadu
Salem
TAMIL NADU
636308
India |
| Phone |
9842780556 |
| Fax |
|
| Email |
drjsenthil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions homoeopathic medical college and Hospital nh 47 sankari main road seeragapadi
salem
Tamilnadu
|
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions homoeopathic medical college and Hospital |
| Address |
nh 47 sankari main road seeragapadi salem
Tamilnadu
|
| 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 j senthilkumar |
vinayaka missions homoeopathic medical college |
Department of repertory
opd room no 3c
Vinayaka Missions homoeopathic medical college and Hospital NH 47 sankari main road seeragapadi
Salem
Tamilnadu
Salem
TAMIL NADU |
9842780556
drjsenthil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee Vinayaka missions Kirupananda Variyar medical College and Hospital salem |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N943||Premenstrual tension syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic medicines |
Homoeopathic medicines are selected on basis of individualisation and dose selected on susceptability of patient medicine is administered via oral route followup is taken in every 15 days maximum treatment period for patient under study is 6 months |
| Comparator Agent |
not applicable
|
not applicable |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Female |
| Details |
Young Adolescents girls (17-24) who experience PMS on monthly basis
Cases were considered on basis of American College of Obstetricians and Gynecologist Criteria |
|
| ExclusionCriteria |
| Details |
Age group below 17 and above 24 females are excluded.
Pregnant and menopausal or peri menopausal females are excluded.
Lactating females.
Cases with congenital anomalities.
Cases with gross pathological changes.
Girls with irregular menstrual cycles.
Cases with pre diagnosed mood disorders anxiety and depression.
Females who had started or changed oral contraceptive pill in the previous 6 months.
Girls in treatment of PMS
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| based on American College of Obstetricians and Gynecologist Criteria clinical symptoms of premenstrual syndrome are assesed |
after 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
It is expected that the proposed Study will be useful in reducing the Symptoms of premenstrual syndrome and To improve the quality of life of the patients
|
after 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
|
Phase 4 |
|
Date of First Enrollment (India)
|
11/04/2022 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Premenstrual
syndrome (PMS) is a common health problem in women in reproductive age group. Premenstrual
syndrome is also described as Premenstrual Tension Syndrome, it is a symptom
complex recognized primarily by cyclic changes associated with ovulatory
cycles. Homoeopathy
is one of the most popular holistic systems of medicine. The selection of
remedy is based upon the theory of individualization and symptoms similarity by
using holistic approach.SYNTHESIS9.1 REPERTORY
is more effective and most authenticated repertory in treatment of Premenstrual
Syndrome, as there is mental aspect that can be a leading cause of the disease.
So, in my dissertation on Premenstrual Syndrome, I have chosen SYNTHESIS 9.1
REPERTORY |