| CTRI Number |
CTRI/2018/06/014498 [Registered on: 11/06/2018] Trial Registered Prospectively |
| Last Modified On: |
30/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of zinc sulphate on menstrual cramps |
|
Scientific Title of Study
|
A PROSPECTIVE INTERVENTIONAL STUDY FOR THE ROLE OF ZINC SULPHATE ON PAIN SEVERITY AND DURATION IN PRIMARY DYSMENORRHEA |
| Trial Acronym |
ZNDY |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ravali Ch |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8008019111 |
| Fax |
|
| Email |
ravali.rau90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayaraman Nambiar |
| Designation |
Professor |
| Affiliation |
|
| Address |
Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
drramnambiar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravali Ch |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Kasturba Medical College, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8008019111 |
| Fax |
|
| Email |
ravali.rau90@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Ravali Ch |
| Address |
Department Of OBG, KMC, Manipal |
| Type of Sponsor |
Other [] |
|
|
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 Ravali Ch |
Kasturba hospital |
KMC, Manipal
Udupi
KARNATAKA |
8008019111
ravali.rau90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
primary dysmenorrhea, (1) ICD-10 Condition: N944||Primary dysmenorrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Regular menstrual cycles (every 28 +/- 7 days) and with a history of primary dysmenorrhea for at least one day per month |
|
| ExclusionCriteria |
| Details |
Evidence of gynecological disease (such as endometriosis, adenomyosis), significant
medical history, women on antibiotics such as Quinolones, tetracycline’s and on
thiazides, Penicillamine are excluded from the study |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| decrease in pain severity and duration |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life |
3 months |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
11/06/2018 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Patients presenting to the OPD of Kasturba Hospital, Manipal with primary dysmenorrhea are included in the study.Written and informed consent will be taken from the participants for inclusion in the study. Alternate Patients will be prescribed zinc sulphate + mefenamic acid and mefenamic acid alone. Pain severity and duration will be compared between these two groups. Pain severity, by visual analogue scale, and pain duration are measured over 3 cycles. Mean pain duration and severity are calculated for the participants and compared to know the significance. |