| CTRI Number |
CTRI/2025/01/079538 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
25/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The Role of Synthetic Repertory in Addressing Pre-Menstrual Syndrome |
|
Scientific Title of Study
|
Scope of Synthetic Repertory in cases of Premenstrual Syndrome |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rishita Rashmikant Shah |
| Designation |
M.D. Scholar part - 2 |
| Affiliation |
cd pachchigar college of homoeopathic medicine and hospital |
| Address |
Department Of Case Taking And Repertory Division Of MD 2nd floor CD Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat
Department Of Case Taking And Repertory Division Of MD 2nd floor CD Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat
Surat
GUJARAT
395001
India |
| Phone |
9913222139 |
| Fax |
|
| Email |
rishushah74@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shrirang N Vyas |
| Designation |
M.D. (Hom.) |
| Affiliation |
cd pachchigar college of homoeopathic medicine and hospital |
| Address |
Department Of Case Taking And Repertory Division Of MD 2nd floor CD Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat
Department Of Case Taking And Repertory Division Of MD 2nd floor CD Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat
Surat
GUJARAT
395001
India |
| Phone |
09426185880 |
| Fax |
|
| Email |
drsnvyas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shrirang N Vyas |
| Designation |
M.D. (Hom.) |
| Affiliation |
cd pachchigar college of homoeopathic medicine and hospital |
| Address |
Department Of Case Taking And Repertory Division Of MD 2nd floor CD Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat
Department Of Case Taking And Repertory Division Of MD 2nd floor CD Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat
GUJARAT
395001
India |
| Phone |
09426185880 |
| Fax |
|
| Email |
drsnvyas@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Case Taking And Repertory Division Of MD 2nd floor CD Pachchigar College of Homoeopathic Medicine and Hospital Surat 395001 Gujarat |
|
|
Primary Sponsor
|
| Name |
C D Pachchigar college of homoeopathic medicine and Hospital |
| Address |
near Anand Mangal Society, Udhana Magdalla Road, Surat-395001 |
| 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 |
| rishita rashmikant shah |
C D Pachchigar College Of Homoeopathic Medicine And Hospital |
Department Of Case Taking And Repertory Division Of MD 2nd floor CD Pachchigar College of Homoeopathic Medicine and Hospital Surat Gujarat
Surat
GUJARAT |
9913222139
rishushah74@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of C.D. Pachchigar College of Homoeopathic Medicine And Hopsital |
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 Medicine |
Homoeopathic Medicine as per requirement of case through sublingual mode of administration within time duration of 9 months |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
All female patient suffering from Premenstrual Syndrome between Menarche and Menopause.
Female who have regular menses.
|
|
| ExclusionCriteria |
| Details |
Patient suffering from Premenstrual Syndrome with any associated Pathology.
Patient suffering from any Congenital Anomalies.
Female who is taking Oral Contraceptive Pills.
Patient with any Endocrinal, Psychiatric and Neurological disorder.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to remove the symptoms of Premenstrual symptoms |
Removal Of Symptoms Of The Patient Depends On The Condition Of The Patient Probably 1 To 3 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improve the life style of patient |
As per requirement of case |
|
|
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)
|
07/02/2025 |
| 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="9"
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
|
Premenstrual syndrome (PMS) is a combination of symptoms that many women get about a week or two before their period. Though the word ‘Premenstrual’ is belongs to only one organ, but it has effect on whole body including physical and behavioural or psychological changes. Dr.Barthel produced a combined work of all repertories and materia medica in the form of Synthetic Repertory, which is an up to date repertory of general symptoms of Homoeopathic Materia Medica compiled by Dr. H. Barthel, Wiesbaden and Dr. Will Klunker. With all the biological parameters there are women who have minimal or no symptoms while similar number have such severe symptoms that there is major impairment of their lives, their families, their inter-personal relationships and normal day to day functioning. So by this study we can aware people about effectiveness of Homoeopathic medicine in cases of PreMenstrual Syndrome & also we can minimize complains of the patient to improve quality of living. |