| CTRI Number |
CTRI/2024/08/072678 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
14/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
Homoeopathy in Premenstrual Syndrome |
|
Scientific Title of Study
|
Utility of Individualised Homoeopathic Medicine in cases of Premenstrual Syndrome by repertorizing through Synthesis Repertory |
| 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 Ekta Singh |
| Designation |
BHMS MD Scholar |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College and Hospital |
| Address |
Dept. of case taking and Repertory, Jawaharlal Nehru Homoeopathic Medical College and Hospital, Parul University, Limda, Waghodiya ,Vadodara, Gujarat.
Vadodara
GUJARAT
391760
India |
| Phone |
9824392993 |
| Fax |
|
| Email |
ektasingh140198@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jignesh Patel |
| Designation |
HOD, Case Taking and Repertory |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College and Hospital |
| Address |
Dept. Of Case Taking and Repertory, Jawaharlal Nehru Homoeopathic Medical College Parul University, Limda,Waghodiya
Vadodara
GUJARAT
391760
India |
| Phone |
9909949221 |
| Fax |
|
| Email |
jhpatel2003@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jignesh Patel |
| Designation |
HOD, Case Taking and repertory |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College and Hospital |
| Address |
Dept. of Case Taking and Repertory, Jawaharlal Nehru Homoeopathic Medical College Parul University, Limda ,Waghodiya
Vadodara
GUJARAT
391760
India |
| Phone |
9909949221 |
| Fax |
|
| Email |
jhpatel2003@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Homeopathic Medical College And Hospital, Parul University,Limda,Waghodiya,Vadodara,Gujarat,391760 |
|
|
Primary Sponsor
|
| Name |
Dr Ekta Singh |
| Address |
Jawaharlal Nehru Homoeopathic Medical College and Hospital , Parul University,Limda,Waghodiya,Vadodara,Gujarat,391760 |
| 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 Ekta Singh |
Jawaharlal Nehru Homoeopathic Medical and Hospital |
Room no.103 Dept. Of Gynaecology Jawaharlal Nehru Homoeopathic Medical Hospital, Parul University, Limda, Waghodiya
Vadodara
GUJARAT |
9824392993
ektasingh140198@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jawaharlal Nehru Homoeopathic medical college and hospital institutional ethics committee for human research |
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 |
Belladonna, Bromium, Bovista, Pulsatilla, Sepia, Sarsaparilla , Secale cor etc |
Individualised Homoeopathic Medicines on the basis of repertorization from Synthesis Repertory like Belladonna, Bromium, Bovista, Pulsatilla, Sepia,Sarsaparilla, Secale Cor etc are prescribe to individuals having Premenstrual Syndrome on the basis of strict Homoeopathic principles. Administration of the medicine will follow a sublingual route. A suitable Homoeopathic potency 30,200,1M,etc. will be prescribed as per the necessity of the case. Repetition of the dose of Homoeopathic medicine will be done as per the requirements of the case. The dose will be administered and evaluated until the disappearance of the symptoms of Premenstrual syndrome. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Patient who is pre diagnosed with Premenstrual Syndrome.
2. All socio-economic status
3. Patient who gives consent for participating in study |
|
| ExclusionCriteria |
| Details |
1.Patient suffering from Premenstrual syndrome with any associated pathology
2.Patient suffering from Premenstrual syndrome with any psychiatry disorder
3.Patient who is on oral contraceptive pill
4. Pregnant and Lactating women
5. Patient who is having Perimenopausal phase |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Synthesis Repertory is effective in treating the cases of Premenstrual Syndrome
2. Reduction in symptoms of Premenstrual syndrome |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To know the effectiveness of synthesis repertory in cases of premenstrual syndrome.
2.To clinically assess the treatment outcome in cases of Premenstrual syndrome by using Self assessment scale before and after treatment |
3 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
12/09/2024 |
| 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 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
|
The study is Prospective interventional non-randomized study. By using synthesis repertory individualised Homoeopathic medicine will be selected for the Premenstrual Syndrome Patients the primary outcome is to know the effectivenss of synthesis repertory in cases of premenstrual syndrome and also assessing the before and after treatment outcome by using self made scale. |