| CTRI Number |
CTRI/2024/07/071209 [Registered on: 24/07/2024] Trial Registered Prospectively |
| Last Modified On: |
23/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of using coriander seed and ginger for menstrual pain |
|
Scientific Title of Study
|
Effect of coriander seed and ginger on pain and inflammatory markers among individuals with primary dysmenorrhoea |
| 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 Roopa MG |
| Designation |
PG Student |
| Affiliation |
SDM College of naturopathy and yogic science ujire |
| Address |
Department of Nutrition and Dietetics
SDM College of naturopathy and yogic science ujire, Belthangadi Dakshina Kannada - 574240 Karnataka India
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9972754806 |
| Fax |
|
| Email |
roopamg04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roopa MG |
| Designation |
PG Student |
| Affiliation |
SDM College of naturopathy and yogic science ujire |
| Address |
Department of Nutrition and Dietetics
SDM College of naturopathy and yogic science ujire, Belthangadi Dakshina Kannada - 574240 Karnataka India
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9972754806 |
| Fax |
|
| Email |
roopamg04@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prashanth Shetty |
| Designation |
Principal And Dean Division Of Nutrition And Dietetics |
| Affiliation |
SDM College of naturopathy and yogic science ujire |
| Address |
SDM College of naturopathy and yogic science ujire, Belthangadi Dakshina Kannada - 574240 Karnataka India
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9448252696 |
| Fax |
|
| Email |
drprashanth9@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM Residential hostels ujire, Belthangadi, Dakshina Kannada - 574240 |
|
|
Primary Sponsor
|
| Name |
Dr Roopa MG |
| Address |
SDM College Of Naturopathy And Yogic Science Ujire, Belthangadi, Dakshina Kannada - 574240 |
| 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 Roopa MG |
Shri Dharmasthala Manjunatheshwara Yoga And Nature Cure Hospital Shantivana |
COE, Department of Nutrition And Dietetic Shantivana Dharmasthala Belthangadi Dakshina kannada - 574216
Dakshina Kannada
KARNATAKA |
9972754806
roopamg04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Institutional Ethical Committee |
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 |
Coriander seed |
consumption of 2gms of coriander seed powder with 200ml of normal water for 12 weeks |
| Comparator Agent |
Coriander seed and Ginger |
consumption of 1gm of coriander seed and 1gm of ginger powder in 200ml of normal water for 12 weeks |
| Intervention |
Ginger |
consumption of 2gm of ginger powder in 200ml of normal water for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
1. Females aged from 17 years to 25 years
2. Females with the history of primary dysmenorrhea at least from past 1 year
3. Females with regular menstrual cycle with period varied from 21 to 35 days |
|
| ExclusionCriteria |
| Details |
1. Females suffering from dysmenorrhoea due to an underlying pelvic pathological condition (secondary dysmenorrhoea).
2. Females on medication for dysmenorrhoea
3. Females with oral contraceptive pills, intra uterine devices and under medication for dysmenorrhea.
4. History of abnormal uterine bleeding
5. Females with pelvic infections.
6. Females with history of psychiatric illness.
7. Females with regular use of medication for any disease.
8. Any allergy to ginger and coriander seeds. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Visual Analogue score |
pre intervention on first day of menstrual cycle after recruiting to the study.
post intervention on first day of menstrual cycle after completion of 12 week intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Erythrocyte Sedimentation Rate
2. neutrophil - lymphocyte ratio
3. MOOS Menstrual Distress Questionnaire |
pre intervention on first day of menstrual cycle after recruiting to the study.
post intervention on first day of menstrual cycle after completion of 12 week intervention |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
30/08/2024 |
| 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="4"
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
|
Clinically there is no significant study on coriander seed for dysmenorrhea and no study on combined effect of coriander and ginger on pain and inflammation among the individuals with primary dysmenorrhea. Hence this three arm study hypothesize that there would be a significant difference on females with primary dysmenorrhea by the intervention for 12 weeks . |