| CTRI Number |
CTRI/2025/09/095323 [Registered on: 24/09/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Checking how well the Homoeopathic medicine Viburnum Opulus 30C works to improve the daily life of young unmarried girls who suffer from period pain using the WaLIDD score |
|
Scientific Title of Study
|
Clinical Evaluation Of The Effectiveness Of Homoeopathic Medicine Viburnum Opulus 30c In Improving Quality Of Life Of Unmarried Females With
Primary Dysmenorrhoea Using WaLIDD Score |
| 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 VISMITH GLORY S V |
| Designation |
Junior Resident, Department Of Homoeopathic Materia Medica |
| Affiliation |
White Memorial Homoeo Medical College and Hospital |
| Address |
Department of Homoeopathic Materia Medica, White Memorial Homoeo Medical College and Hospital, Attoor, Veeyanoor, Kanniyakumari
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9447271874 |
| Fax |
|
| Email |
vismithglory13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K MANIKANDA PERUMAL |
| Designation |
PROFESSOR Department of Homoeopathic Materia Medica |
| Affiliation |
White Memorial Homoeo Medical College and Hospital |
| Address |
Department of Homoeopathic Materia Medica, White Memorial Homoeo Medical College and Hospital, Attoor, Veeyanoor, Kanniyakumari
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9787925186 |
| Fax |
|
| Email |
dr.perumal007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K MANIKANDA PERUMAL |
| Designation |
PROFESSOR Department of Homoeopathic Materia Medica |
| Affiliation |
White Memorial Homoeo Medical College and Hospital |
| Address |
Department of Homoeopathic Materia Medica, White Memorial Homoeo Medical College and Hospital, Attoor, Veeyanoor, Kanniyakumari
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9787925186 |
| Fax |
|
| Email |
dr.perumal007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Homoeopathic Materia Medica, White Memorial Homoeo Medical College And Hospital Attoor, Kanniyakumari, Tamilnadu. Pin 629177. India |
|
|
Primary Sponsor
|
| Name |
Department Of Homoeopathic Materia Medica White Memorial Homoeo Medical College And Hospital |
| Address |
White Memorial Homoeo Medical College And Hospital Attoor, Kanniyakumari, Tamilnadu. Pin 629177. India |
| 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 VISMITH GLORY S V |
White Memorial Homoeo Medical College And Hospital |
Department of Homoeopathic Materia Medica, White Memorial Homoeo Medical College and Hospital, Attoor, Veeyanoor PO, Kanniyakumari, Tamilnadu, India Pin 629177
Kanniyakumari
TAMIL NADU |
9447271874
vismithglory13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| WHITE MEMORIAL HOMOEO MEDICAL COLLEGE AND HOSPITAL ETHICS COMMITTEE WMHMCH-EC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N944||Primary dysmenorrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
VIBURNUM OPULUS 30C |
Case taking, Potency selection and Medicine administration according to Homoeopathic principle.
Homoeopathic medicine Viburnum opulus 30c will be administered.
Patients are advised to take four pills (size 40 globules) medicated with Viburnum opulus 30C, three times daily before food, starting from the onset
of symptoms until the menstrual flow ceases.
Repetition in subsequent cycles: If improvement is observed, the medicine should be taken only during the menstrual phase, and discontinued once symptoms no longer appear during menstruation. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
Menstrual cycle:Regular menstrual cycle (21-35 days)and duration of flow 4-5 days.
Patient with WaLIDD Score above 4
Patient with consent and parent consent.
Patients with indicated symptoms of Viburnum Opulus. |
|
| ExclusionCriteria |
| Details |
Age group below 15 and above 25 years.
Marital status : Married
Secondary Dysmenorrhoea due to underlying medical conditions (e.g.: endometriosis, fibroids, pelvic inflammatory disease, PCOS etc)
Presence of other gynaecological conditions.
Current use of hormonal contraceptives. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of improvement in quality of life will be done by comparing WaLIDD Score before and after the treatment.
Outcome will be classified as follows:
Mild improvement: 1-33%
Moderate improvement: 34-66%
Marked improvement: 67-99% |
6 m0nths |
|
|
Secondary Outcome
|
|
|
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)
|
01/10/2025 |
| 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="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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - all data to be provided when needed through email vismithglory13@gmail.com
- For how long will this data be available start date provided 01-01-2028 and end date provided 01-01-2035?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Dysmenorrhoea is defined as painful pelvic cramping associated with menses, which may be associated with low back and thigh pain, headache, nausea, diarrhea, and fatigue. Symptoms often start a few days before menses and last through the first few days of bleeding. Many women are affected by this condition, with estimates ranging from 16%-97%. Primary dysmenorrhoea, not explained by an alternative diagnosis, is thought to be secondary to elevated prostaglandin levels that cause uterine hyper contractility and subsequent ischemia. Associated symptoms, including pain and nausea, can also be explained by high prostaglandin levels. Secondary causes of dysmenorrhoea must be ruled out, including infection, cervical stenosis, adenomyosis, fibroids, or endometriosis. The standard approach to treatment of dysmenorrhoea includes NSAIDs and hormonal contraception, both of which help to suppress prostaglandin production. Research supports the use of many self-care and complementary approaches that should also be considered.Conventional management strategies primarily include non-steroidal anti- inflammatory drugs (NSAIDs) and hormonal therapy. However, these treatments are often associated with side effects, and not all individuals experience adequate relief. This has led to increased interest in complementary and alternative therapies, including Homoeopathy, which offers a holistic and individualized approach to treatment.Viburnum opulus, also known as Cramp Bark, is a well-established homoeopathic remedy traditionally indicated for uterine cramps and spasmodic dysmenorrhoea. While there is anecdotal and materia medica-based support for its use, limited clinical evidence exists, especially in the context of standardized outcome measures.Despite the high prevalence of primary dysmenorrhoea among adolescent and young adult females, there is a limited body of clinical research supporting the use of specific Homoeopathic remedies like Viburnum opulus 30C in its management. While Viburnum opulus is historically indicated in materia medica for menstrual cramps and spasmodic dysmenorrhoea, few scientifically validated studies exist that quantify its efficacy using standardized assessment tools such as the WaLIDD score. Additionally, there is a lack of evidence-based homoeopathic protocols for primary dysmenorrhoea specifically among unmarried females in the Indian population. This demographic is often underrepresented in clinical research, despite experiencing high rates of dysmenorrhoea. Therefore, this study aims to fill the gap by applying a standardized and validated scoring tool(WaLIDD), evaluating a single, clinically-indicated homoeopathic remedy and focusing on a specific yet commonly affected demographic group.Cases will be taken from the outpatient, inpatient and peripheral centers of White Memorial Homoeo Medical College and Hospital. A minimum 30 cases are selected based on participant screening questionnaire.Cases will be taken in detail and recorded in case record formulated as per WMHMC & hospital. Clinical examination and investigation done if necessary. Homoeopathic medicine Viburnum opulus 30c will be administered. Patients are advised to take four pills (size 40 globules) medicated with Viburnum opulus 30C, three times daily before food, starting from the onset of symptoms until the menstrual flow ceases. Repetition in subsequent cycles: If improvement is observed, the medicine should be taken only during the menstrual phase, and discontinued once symptoms no longer appear during menstruation.Analysis will be done comparing the value of WaLIDD score before and after treatment.The statistical analysis will be done using normality tests, descriptive statistics, paired t-test. After analysis data will be interpret and results will be summarized. |