| CTRI Number |
CTRI/2026/02/102912 [Registered on: 03/02/2026] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy
Other (Specify) [Constitutional homoeopathic medicine] |
| Study Design |
Other |
|
Public Title of Study
|
To study role of constitutional homoeopathic medicines in management of premenstrual syndrome |
|
Scientific Title of Study
|
Utility of constitutional homoeopathic medicines in management of premenstrual tension syndrome by using premenstrual syndrome scale An uncontrolled 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 Shraddha Nanasaheb Gaikwad |
| Designation |
PG Scholar |
| Affiliation |
Dr J J Magdum homoeopathic medical college jaysingpur |
| Address |
Department Of Organon of medicine and homoeopathic philosophy division homoeopathy room no 16
Dr J J Magdum homoeopathic college shirol wadi road laxmi nagar jaysingpur tal shirol dist kolhapur
Kolhapur
MAHARASHTRA
416101
India |
| Phone |
9067630352 |
| Fax |
|
| Email |
shraddhagaikwad883@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arati Patil |
| Designation |
Guide and professor |
| Affiliation |
Dr J J Magdum homoeopathic medical college jaysingpur |
| Address |
Department Of Organon of medicine and homoeopathic philosophy division homoeopathy room no 16
Dr J J Magdum homoeopathic college shirol wadi road laxmi nagar jaysingpur tal shirol dist kolhapur
Kolhapur
MAHARASHTRA
416101
India |
| Phone |
9403450457 |
| Fax |
|
| Email |
draratipatil45@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shraddha Nanasaheb Gaikwad |
| Designation |
PG Scholar |
| Affiliation |
Dr J J Magdum homoeopathic medical college jaysingpur |
| Address |
Department Of Organon of medicine and homoeopathic philosophy division homoeopathy room no 16
Dr J J Magdum homoeopathic college shirol wadi road laxmi nagar jaysingpur tal shirol dist kolhapur
Kolhapur
MAHARASHTRA
416101
India |
| Phone |
9067630352 |
| Fax |
|
| Email |
shraddhagaikwad883@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr j j Magdum homoeopathic medical college shirol wadi road laxmi nagar jaysingpur tal shirol dist kolhapur 416101 |
|
|
Primary Sponsor
|
| Name |
Dr Shraddha Nanasaheb Gaikwad |
| Address |
Dr J J Magdum Homoeopathic Medical college shirol wadi road laxmi nagar jaysingpur tal shirol dist kolhapur 416101 |
| Type of Sponsor |
Other [self sponsored] |
|
|
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 Shraddha Nanasaheb Gaikwad |
Dr j j magdum homoeopathic medical college hospital jaysingpur |
Department of organon of medicine and homoeopathic philosophy division homoeopathy room no 16 Dr j j Magdum homoeopathic medical college shirol wadi road laxmi nagar jaysingpur tal shirol dist kolhapur 416101
Kolhapur
MAHARASHTRA |
9067630352
shraddhagaikwad883@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr j j magdum homoeopathic medical college |
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 |
Constitutional homoeopathic medicine |
Homoeopathic management using constitutional homoeopathic medicines as per individual case dose potency and frequency depending upon susceptibility of individual oral administration duration of intervention according to need of the case |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
All the patients who score more than 80 in premenstrual syndrome scale
Females between 15-49 years of age group
Patients suffering from premenstrual syndrome willing to participate and taking treatment regularly and co-operating for regular follow up will be included |
|
| ExclusionCriteria |
| Details |
The patient not fulfilling the case definition of Premenstrual Syndrome
Patients with pelvic pathology congestive membranous and obstructive dysmenorrhea will be excluded
Patients suffering from severe form of Premenstrual syndrome which is Premenstrual Dysphoric Disorder
Patients on chronic medication that might interfere with symptoms of premenstrual syndrome eg hypothyroidism Diabetes Mellitus psychiatric illness were on hormonal treatment except an OCP pills |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome assessment will be done by applying premenstrual syndrome scale |
Outcome assessment will be done by applying premenstrual syndrome scale score from baseline to 3 consecutive menstrual cycles (approximately 12 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
16/02/2026 |
| 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="6"
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
|
An uncontrolled clinical trial designed to evaluate the utility of constitutional homoeopathic medicines in reducing the severity of premenstrual tension syndrome This Study will be undertaken for 1 year and 6 months Sample size will be 30 outcome assessment will be done using premenstrual syndrome scale After data collection data will be analyzed and evaluated with appropriate statistical test |