| CTRI Number |
CTRI/2026/01/102343 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
27/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Study to Find Out Whether the Homeopathic Medicine Folliculinum Can Reduce pre menstrual syndrome in Women Aged 15–35 Years |
|
Scientific Title of Study
|
A Prospective Single arm study to evaluate the effectiveness of Folliculinum 30C in reducing premenstrual syndrome symptoms using PMMS in women aged 15 to 35 |
| 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 Pindi Sowmya |
| Designation |
PG Scholar |
| Affiliation |
JIMS Homoeopathic Medical College and Hospital |
| Address |
OPD no 7 Department of Homoeopathic Materia Medica JIMS Homoeopathic Medical College and Hospital Sriramnagar Muchintal Palamakula PO Shamshabad Mandal Hyderabad Telangana India 509325
Hyderabad
TELANGANA
509325
India |
| Phone |
8074115804 |
| Fax |
04023470444 |
| Email |
spindi977@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjali Manayil |
| Designation |
Associate Professor |
| Affiliation |
JIMS Homoeopathic Medical College and Hospital |
| Address |
OPD no 7 Department of Homoeopathic Materia Medica JIMS Homoeopathic Medical College and Hospital Sriramnagar Muchintal Palamakula PO Shamshabad Mandal Hyderabad Telangana India 509325
Hyderabad
TELANGANA
509325
India |
| Phone |
8075354494 |
| Fax |
04023470444 |
| Email |
manayilanjali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pindi Sowmya |
| Designation |
PG Scholar |
| Affiliation |
JIMS Homoeopathic Medical College and Hospital |
| Address |
OPD no 7 Department of Homoeopathic Materia Medica JIMS Homoeopathic Medical College and Hospital Sriramnagar Muchintal Palamakula PO Shamshabad Mandal Hyderabad Telangana India 509325
Hyderabad
TELANGANA
509325
India |
| Phone |
8074115804 |
| Fax |
04023470444 |
| Email |
spindi977@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JIMS HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
JIMS HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL SRIRAM NAGAR MUCHINTAL PALAMAKULA SHAMSHABAD RANGA REDDY DISTRICT HYDERABAD TELANGANA 509325 |
| 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 Pindi Sowmya |
JIMS Homoeopathic Medical College and Hospital |
OPD no 7 Department of Homoeopathic Materia Medica JIMS Homoeopathic Medical College and Hospital Sriramnagar Muchintal Palamakula PO Shamshabad Mandal Hyderabad Telangana India 509325
Hyderabad
TELANGANA |
8074115804
04023470444
spindi977@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIMS Homoeopathic Medical College and Hospital |
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 |
Folliculinum 30C |
Folliculinum 30C will be administered in single dose 4 pills orally given 1 week before menses on empty stomach for a period of 4 months |
| Comparator Agent |
Placebo |
Placebo with counselling |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Participants clinically diagnosed as per ACOG criteria premenstrual symptoms not
linked to any organic lesions typically occur during the luteal phase of ovulatory
cycles and resolve afterward must be severe enough to impact daily life or require
medical attention, they may be classified as Premenstrual Dysphoric Disorder
PMDD
between the age group 15 to 35 years having Regular Menses for past 6 months presenting with a Pelvic USG scan finding of within normal pelvic
pathology for female reproductive organs |
|
| ExclusionCriteria |
| Details |
Participants presenting with organic pelvic lesions or irregular menstrual cycles as well as those with psychiatric comorbidities such as depression or anxiety requiring pharmacological treatment were excluded from the study Individuals currently undergoing hormonal therapy were also not considered eligible Additionally participants with thyroid disorders or other systemic conditions including fibroids PCOD or cysts in the uterus or ovaries—were excluded Those already receiving complementary and alternative medicine (CAM) therapies were also not included in the study sample |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Evaluate the effectiveness of Folliculinum 30 C in reducing the
PMS Scale for a period of 4 months |
Baseline second and fourth month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
15/02/2026 |
| 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="2"
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 is a common condition affecting women of reproductive age and is characterised by recurring physical emotional and behavioural symptoms during the luteal phase which interfere with daily functioning Conventional treatment options often produce adverse effects or offer limited relief creating a need for safer holistic approaches Folliculinum a homoeopathic sarcode prepared from potentised oestrogen is believed to help restore hormonal balance and improve emotional and physical well being in women experiencing PMS symptoms This study proposes a prospective randomized controlled trial to evaluate the effectiveness of Folliculinum 30C in reducing PMS symptoms in women aged fifteen to thirty five A total of seventy five participants fulfilling ACOG criteria will be selected from OPD IPD and peripheral centres of JIMS Homoeopathic Medical College and Hospital Participants will be randomly allocated into two groups the trial group receiving Folliculinum 30C and the control group receiving placebo with counselling Symptom changes will be assessed using the Premenstrual Syndrome Scale at baseline two months and four months Ethical clearance has been obtained and strict inclusion exclusion criteria will be followed Data will be analysed using non parametric statistical methods The study aims to generate evidence supporting the clinical usefulness of Folliculinum 30C as a safe and effective mode of treatment in premenstrual syndrome |