| CTRI Number |
CTRI/2026/02/103783 [Registered on: 12/02/2026] Trial Registered Prospectively |
| Last Modified On: |
12/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Homoeopathic treatment of premenstrual syndrome. |
|
Scientific Title of Study
|
A comparative study on the effectiveness of individualised homeopathic medicine in centisimal versus LM potency in the management of premenstrual syndrome with its miasmatic analysis : a prospective open - label double - arm interventional 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 |
Km Mantasha Aslam |
| Designation |
Post graduate trainee |
| Affiliation |
State National Homoeopathic Medical College and Hospital |
| Address |
Depart Of organon of medicine and Homoeopathic philosophy State National Homoepathic Medical College and Hospital
Viraj Khand 1 Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8700984267 |
| Fax |
|
| Email |
amantashaaslam.ansari178@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shashi Arya |
| Designation |
Lecturer |
| Affiliation |
State National Homoepathic Medical College and Hospital |
| Address |
Depart of organon of medicine and Homoeopathic philosophy State National Homoeopathic Medical College and Hospital
Viraj Khand 1 Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9450417584 |
| Fax |
|
| Email |
drshashiarya2105@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Km Mantasha Aslam |
| Designation |
Post graduate trainee |
| Affiliation |
State National Homoepathic Medical College and Hospital |
| Address |
Organon of medicine and homoe Philosophy State National Homoepathic Medical College and Hospital
Viraj Khand 1 Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8700984267 |
| Fax |
|
| Email |
amantashaaslam.ansari178@gmail.com |
|
|
Source of Monetary or Material Support
|
| Out patient department of State National Homoeopathic medical college and hospital Viraj Khand 1 Gomti nagar Lucknow Uttar Pradesh 226010 |
|
|
Primary Sponsor
|
| Name |
Km Mantasha Aslam |
| Address |
Department of Organon of medicine and Homoeopathic philosophy State National Homoeopathic Medical College and Hospital
Viraj Khand 1 Gomti nagar Lucknow Uttar Pradesh 226010 |
| 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 Km Mantasha Aslam |
State National Homoeopathic Medical Colllege and Hospital Lucknow |
OPD-5 Department of Organon of Medicine and Homoeopathic Philosophy State National Homoeopathic Medical and Hospital Viraj Khand 1 Gomti Nagar
Lucknow
UTTAR PRADESH |
8700984267
amantashaaslam.ansari178@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of State National Homoeopathic Medical College and Hospital Lucknow |
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 |
| Comparator Agent |
Individualised homoeopathic medicine in centisimal potency. |
Patient qualifying to inclusion criteria will be taken into study. After proper case taking, analysis and evaluation will be done with the aid of suitable repertory. Homoeopathic medicine will be selected on the basis of repertization. Indicated medicine will be given in centisimal potency via oral route of administration. Medicine will be given in globules form. Potency selection and repetition will be done according to the patient’s susceptibility and stage of disease. Each case will be followed up at regular interval preferably at a period of 15 days. Each patients will be evaluated after 6 months using ‘premenstrual syndrome scale’ and SF-12 health survey questionnaire. |
| Intervention |
Individualised Homoeopathic medicine in LM potency. |
Patient qualifying to inclusion criteria will be taken into study. After proper case taking, analysis and evaluation will be done with the aid of suitable repertory. Homoeopathic medicine will be selected on the basis of repertization. Indicated medicine will be given in LM potency via oral route of administration. Medicine will be given in liquid form, water being the vehicle in 100 mL amber color bottle. 1 tbsp is added in a cup of water is to be considered as 1st dose. Subsequent doses will be taken after giving 10 strokes to the bottle. Repetition of doses will be done according to patient’s susceptibility and stage of disease. Each case will be followed up at regular interval preferably at a period of 15 days. Each patients will be evaluated after 6 months using ‘premenstrual syndrome scale’ and SF-12 health survey questionnaire. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Patient with age group 18yrs to 45yrs having symptoms of PMS for more than 3 months.
Patients having regular menstrual cycle.
Patients fulfilling premenstrual screening criteria.
Patients who can give informed consent and comply with study procedure. |
|
| ExclusionCriteria |
| Details |
Patient suffering from psychiatric disease.
Patient suffering from known chronic systemic illness eg epilepsy, digestive, cardiovascular, renal and endocrine disorders.
Patient taking hormonal pills.
Pregnant, lactating and menopausal females.
Patient suffering from PMDD.
Patient having abnormal USG finding eg endometriosis, that can mimic PMS.
Patient with age group less than 18yrs and greater than 45 yrs. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome assessment will be done using Premenstrual syndrome scale. |
Primary outcome will be assessed using premenstrual syndrome scale at the interval of 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome assessment will be done using The short form 12 health survey (SF-12). |
Secondary outcome will be assessed using SF-12 at the interval of 3 months. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
23/02/2026 |
| 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
|
Premenstrual syndrome encompasses clinically significant somatic and psychological manifestation during the luteal phase of menstrual cycle, leading to substantial distress and impairment in functional capacity. Epidemiological studies have revealed that about 80% to 90% of women manifest at least one of the PMS signs, however in about 2.5% to 3% of women the syndrome severe enough to affect their activities and social communication. The prevalence of pms is 47.8% worldwide among reproductive age group. At the end of study, it is expected that individualised Homoeopathic medicine chosen with the help of characteristics symptoms and repertory will show effective result in treatment of premenstrual syndrome. The study will prove the effectiveness of Homoeopathic individualised medicine in centisimal and LM potency. The study will determined different causes and management related to premenstrual syndrome and predict the outcome of individualised Homoeopathic medicine in improving the quality of life of patient.
|