| CTRI Number |
CTRI/2024/04/065469 [Registered on: 09/04/2024] Trial Registered Prospectively |
| Last Modified On: |
21/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to Determine the Role of Thea chinensis in Managing Spasmodic and Painful Cramps During Menstruation in Lower Abdomen in Absence of Any Pelvic Pathology. |
|
Scientific Title of Study
|
To Study the Effectiveness of Thea chinensis in the Treatment of
Primary Dysmenorrhoea: A Prospective Uncontrolled
Experimental 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 |
Dr Sristi Chakraborty |
| Designation |
PG Scholar |
| Affiliation |
Dr MPK Homoeopathic Medical College Hospital and Research Centre |
| Address |
Department of Materia medica
Dr MPK Homoeopathic Medical College Hospital and Research Centre A Constituent College of Homoeopathy University Saipura Sanganer Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
9432370196 |
| Fax |
|
| Email |
sristichakraborty1234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonia Tuteja |
| Designation |
Professor Department of Materia Medica |
| Affiliation |
Dr MPK Homoeopathic Medical College Hospital and Research Centre |
| Address |
Department of Materia medica
Dr MPK Homoeopathic Medical College Hospital and Research Centre A Constituent College of Homoeopathy University Saipura Sanganer Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
9530454132 |
| Fax |
|
| Email |
soniatuteja860@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sristi Chakraborty |
| Designation |
PG Scholar |
| Affiliation |
Dr MPK Homoeopathic Medical College Hospital and Research Centre |
| Address |
Department of Materia medica
Dr MPK Homoeopathic Medical College Hospital and Research Centre A Constituent College of Homoeopathy University Saipura Sanganer Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
9432370196 |
| Fax |
|
| Email |
sristichakraborty1234@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Materia Medica Dr Girendra Pal Homoeopathic Hospital and Research Centre Collegiate Hospital Of Dr MPK Homoeopathic Medical College Hospital and Research Centre A Constituent College of Homoeopathy University Saipura Sanganer Jaipur 302029 |
|
|
Primary Sponsor
|
| Name |
Dr MPK Homoeopathic Medical College, Hospital and Research Centre |
| Address |
Plot no 10,11,12 Saipura Sanganer Jaipur
Pincode 302029 |
| 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 Sristi Chakraborty |
Dr Girendra Pal Homoeopathic Hospital and Research Centre |
Department of Materia Medica, Room No. 4, Unit 1, Dr MPK Homoeopathic Medical College, Hospital and Research Centre, Homoeopathy University, Plot no. 10,11,12 Saipura Sanganer Jaipur
Pincode 302029
Jaipur
RAJASTHAN |
9432370196
sristichakraborty1234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Homoeopathy University Jaipur |
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 |
Thea chinensis |
Oral administration of Thea chinensis 30C two globules of size 40, dose and repetition- TDS for 3days or as long as the pain persists and Placebo two globules of size 40, dose and repetition- TDS for rest of the days of the month. Total duration- 3 consecutive menstrual cycle. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Patient giving assent/consent for the study.
2. Any 2 symptoms of the patient corresponding to Thea chinensis:
✓Soreness and tenderness of right ovary/ovaries.
✓Severe cramp like, uterine bearing down pain.
✓Pain from beginning to end of period.
3. Diagnostic criteria: Undiagnosed cases will be enrolled after confirming any of 2 following symptoms observed during menstrual period along with lower abdominal/pelvic pain felt at the right and/or left side of the abdomen.
✓Pain radiating to the thighs and lower back.
✓Nausea and/or vomiting.
✓Diarrhoea/constipation.
✓Mood disturbances. |
|
| ExclusionCriteria |
| Details |
1. Females who are pregnant or lactating.
2. Females suffering from dysmenorrhoea due to Intrauterine Contraceptive Device (IUCDs).
3. Females suffering from dysmenorrhoea due to any pelvic pathology.
4. Patients with other severe systematic disorders.
5. Patients pursing other treatments and are not willing to leave it.
6. Cases requiring emergency/ surgical interventions. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement of the score obtained (pre and post treatment) from WaLIDD score. |
Pre scores will be taken at baseline of treatment and post scores will be assessed at the end of each menstrual cycle till three consecutive cycles. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effectiveness of Thea chinensis in pain management in cases of Primary Dysmenorrhoea. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
22/04/2024 |
| Date of Study Completion (India) |
21/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This study is a prospective, uncontrolled, open label, single arm, unicentric, experimental study to assess the effectiveness of Thea chinensis in managing pain of Primary Dysmeorrhoea. This study will evaluate the extend of improvement in pain due to primary Dysmenorrhoea using WaLIDD score as an assessment scale. The primary outcome will be according to the scores obtained (pre and post treatment) from WaLIDD score. The secondary outcome will assess the effectiveness of Thea chinensis in improving pain due to Primary Dysmenorrhoea. NULL HYPOTHESIS (H0) – Thea chinensis is not effective in managing the pain in cases
of primary dysmenorrhoea. ALTERNATIVE HYPOTHESIS (H1) – Thea chinensis is effective in managing the pain
in cases of primary dysmenorrhoea. |