| CTRI Number |
CTRI/2025/03/082479 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
14/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
HOMOEOPATHIC MANAGEMENT OF SEVERE PREMENSTRUAL SYNDROME(PMDD) |
|
Scientific Title of Study
|
Homoeopathic management of Premenstrual Dysphoric Disorder (PMDD) on the basis of individualisation using Synthesis repertory-
A prospective clinical study
|
| 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 Premalata Rotti |
| Designation |
Associate Professor |
| Affiliation |
A.M.Shaikh homoeopathic medical college and P.G.Research centre |
| Address |
A.M.Shaikh homoeopathic medical college and P.G.Research centre,Nehru nagar,Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
9449919555 |
| Fax |
|
| Email |
drpremlatarotti@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poorav Desai |
| Designation |
Dean & Principal,Professor & HOD in Anatomy |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical college, Parul university,Vadodara. |
| Address |
Jawaharlal Nehru Homoeopathic Medical college, Parul university,P.O.Limda,Ta.Waghodia,Dist.Vadodara,Vadodara,Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9376225507 |
| Fax |
|
| Email |
Poorav.desai@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Premalata Rotti |
| Designation |
Associate Professor |
| Affiliation |
A.M.Shaikh homoeopathic medical college and P.G.Research centre |
| Address |
A.M.Shaikh homoeopathic medical college and P.G.Research centre,
Department of Repertory,
P.G.Section,
Repertory OPD no 1, Nehru nagar, Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
9449919555 |
| Fax |
|
| Email |
drpremlatarotti@yahoo.in |
|
|
Source of Monetary or Material Support
|
| A.M.Shaikh homoeopathic medical college,Hospital & P.G.Research centre,Nehru Nagar,Belagavi-590010,Karnataka,India. |
|
|
Primary Sponsor
|
| Name |
DrPremalata Rotti |
| Address |
A.M.Shaikh homoeopathic medical college,Hospital and P.G.Research centre,Nehru nagar,Belagavi 590010,Karnataka,India. |
| Type of Sponsor |
Other [Principal investigator] |
|
|
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 Premalata Rotti |
A. M. Shaikh homoeopathic medical college Hospital |
Department of Repertory,P.G.Section,Repertory OPD No 1 , Nehru Nagar
Belgaum
KARNATAKA |
9449919555
drpremlatarotti@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee,A.M.Shaikh homoeopathic medical college,Belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F348||Other persistent mood [affective]disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised homoepathic medicines |
These medicines will be selected based on individual charactristics and using Synthesis repertory,after refering materia medica and differentiating with other remedies indicated remedy will be prescribed in suitable potencies(low,medium or high potencies),these medicines will be administered orally as medicated globules, repeatation will be done as per need of the case. |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
41.00 Year(s) |
| Gender |
Female |
| Details |
1.Subjects who fulfill diagnostic criterion for PMDD between 16-41 years
2.Subjects who give informed consent for participation & homoeopathic treatment |
|
| ExclusionCriteria |
| Details |
1.Severe depression due to PMDD to extent of suicidal tendencies
2.Subjects with Hypothyroidism or Hyperthyroidism based on clinical symptoms
3.Subjects on contraceptive pills and who are taking other mode of treatment
4.Major psychiatric disorder
5.Lacation period/Puerperium |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome measures include reduction in mental symptoms which interfere in day today activities.
|
follow up at once in a month for 6 months using MONARCH |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvements in quality of life & overall well being |
changes in WHO-QOL BREF SCALE, 6 months after enrollment |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 |
|
Date of First Enrollment (India)
|
25/03/2025 |
| 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="2"
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
|
Premenstrual dysphoric disorder formerly
loosely known as Premenstrual syndrome.Occurs in the luteal phase of menstrual cycle in
reproductive age group.When searched for
homoeopathic literature not much is available on PMDD.Also the females with PMDD
are treated as PMS but there is variation in both.the objective of the study are :1.To study the effectiveness of homoeopathic medicines
in treating PMDD using synthesis repertory as a tool in selecting medicines.2.To assess the improvement in QOL in females3.To analyse the different presentations of PMDD in different age groups. The anticipated outcome of this study is to provide
evidence regarding the effectiveness of homoeopathic management in treating
PMDD based on individualization using the synthesis repertory. Positive results
would support the use of homoeopathy as a potential alternative or adjunctive
therapy for PMDD, emphasizing the importance of individualized treatment in
this approach. |