| CTRI Number |
CTRI/2023/06/054162 [Registered on: 20/06/2023] Trial Registered Prospectively |
| Last Modified On: |
17/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role Of Homoeopathy In Treatment Of Primary Dysmenorrhea |
|
Scientific Title of Study
|
Usefulness of Individualized Homoeopathic Medicine Along With Miasmatic Approach And Lifestyle Management In Primary Dysmenorrhea - Randomized controlled 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 |
Anju Singh |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic Medical College Greater Noida |
| Address |
Department Of Organon of Medicine
Room no S1 Second Floor Bakson Homoeopathic Medical College And Hospital 36 B Knowledge Park Phase 1
Nil
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9026145849 |
| Fax |
|
| Email |
dr.anjusingh28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anju Singh |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic Medical College Greater Noida |
| Address |
Department Of Organon of Medicine
Room no S1 Second Floor Bakson Homoeopathic Medical College And Hospital 36 B Knowledge Park Phase 1
Nil
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9026145849 |
| Fax |
|
| Email |
dr.anjusingh28@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anuroopam Swami |
| Designation |
Professor |
| Affiliation |
Bakson Homoeopathic Medical College And Hospital |
| Address |
Department Of Organon of Medicine
Room no S1 Second Floor Bakson Homoeopathic Medical College And Hospital36 B Knowledge Park Phase 1
Nil
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9868954687 |
| Fax |
- |
| Email |
anuroopam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bakson Homeopathic Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Bakson Homeopathic Medical College and Hospital |
| Address |
Room No G22
Ground Floor
Bakson Homeopathic Medical College and Hospital
|
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nil |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Anju Singh |
Bakson Homoeopathic Medical College and Hospital |
Room No 1
Ground Floor OPD
Bakson Homeopathic Medical College and Hospital
36 B
Knowledge park 1
Greater Noida
Gautam Buddha Nagar
Gautam Buddha Nagar
UTTAR PRADESH |
9026145849
dr.anjusingh28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Bakson Homeopathic Medical College |
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 |
| Intervention |
Individualised Homoeopathic Medicine |
Oral Route of Administration Pill Form 30 Pill Size Centesimal Scale Prescribed at the start of treatment. Repetition according to follow ups. Follow ups every 4 weeks |
| Comparator Agent |
Nil |
Not Applicable |
| Intervention |
Placebo |
Oral Route of Administration Pill Form 30 Pill Size Centesimal Scale Prescribed at the start of treatment. Repetition according to follow ups. Follow ups every 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Female |
| Details |
1 Patient between 10 years to 19 years for the adolescent age group
2 Pain occurring since menarche as well as pre menopause
3 Clinical features of primary dysmenorrhea must be present during most menstrual cycles which includes pain arising on the first day of menses spasmodic pain and confined to the lower abdomen This pain may radiate to the back and middle aspect of the thigh
4 Those having mild or moderate dysmenorrhea
5 Patients with a regular menstrual cycle of 21-35 days |
|
| ExclusionCriteria |
| Details |
1 patients with regular menstrual cycles of more than 35 days or less than 21 days
2 patients taking any other treatment for any other complaints
3 patient with any other pelvic disease leading to secondary dysmenorrhea sech as fibroid PCOD endometriosis Pelvic Inflammatory Diseases
4 Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Expected reduction in VRS scale |
VRS scale will be used at baseline, 4 weeks, 8 weeks, 12 weeks etc |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Expected reduction in WaLLID Score |
WaLLID score will be done at baseline, 4 weeks, 8 weeks, 12 weeks etc |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
13/07/2023 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study aims to evaluate the effectiveness of individualised homoeopathic treatment and placebo effects in cases of primary dysmenorrhea VRS scale will be used to assess the level of pain at the baseline and then every month. WaLLID scale will be used to assess the daily routine activities of patients with primary dysmenorrhea. |