| CTRI Number |
CTRI/2022/02/039897 [Registered on: 01/02/2022] Trial Registered Prospectively |
| Last Modified On: |
28/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical Study to Evaluate the Efficacy and Safety of OLNP-06 versus Placebo in Subjects with Primary Dysmenorrhea |
|
Scientific Title of Study
|
A Randomized, Double Blind, Placebo Controlled, Parallel Group, Comparative Clinical Study to Evaluate the Efficacy and Safety of OLNP-06 versus Placebo in Subjects with Primary Dysmenorrhea |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjib Panda |
| Designation |
COO |
| Affiliation |
Olene Life Sciences Private Limited |
| Address |
A Block 4th Floor Prince Info Park 81B 2nd Main Road
Ambattur
A-Block, 4th Floor, Prince Info Park, 81-B, 2nd Main Road, Ambattur
Chennai
TAMIL NADU
600058
India |
| Phone |
914440074444 |
| Fax |
|
| Email |
sanjib@olenelife.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjib Panda |
| Designation |
COO |
| Affiliation |
Olene Life Sciences Private Limited |
| Address |
A Block 4th Floor Prince Info Park 81B 2nd Main Road
Ambattur
A-Block, 4th Floor, Prince Info Park, 81-B, 2nd Main Road, Ambattur
Chennai
TAMIL NADU
600058
India |
| Phone |
4440074444 |
| Fax |
|
| Email |
sanjib@olenelife.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjib Panda |
| Designation |
COO |
| Affiliation |
Olene Life Sciences Private Limited |
| Address |
A Block 4th Floor Prince Info Park 81B 2nd Main Road
Ambattur
A-Block, 4th Floor, Prince Info Park, 81-B, 2nd Main Road, Ambattur
Chennai
TAMIL NADU
600058
India |
| Phone |
4440074444 |
| Fax |
|
| Email |
sanjib@olenelife.com |
|
|
Source of Monetary or Material Support
|
| Olene Life Sciences Private Limited |
|
|
Primary Sponsor
|
| Name |
Olene Life Sciences Private Limited |
| Address |
A Block 4th Floor Prince Info Park 81B 2nd Main Road
Ambattur Chennai 600 058 India
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 R Vani Raj |
Chennai Meenakshi Multispeciality Hospital |
Department: Medicine
New No 70, Old No 149, Luz Church Rd,
Mylapore, Chennai 600004.
Chennai
TAMIL NADU |
04442938902
rvani.raj57@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CHENNAI MEENAKSHI MUTTISPTCIATITY HOSPTTAT ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K928||Other specified diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ginger extract |
Ginger extract one capsule once daily for 8 weeks |
| Comparator Agent |
Placebo |
Placebo One capsule Once daily for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Healthy Female subjects 18 – 35 years of age
Regular menstrual cycle between 21 - 35 days with bleeding duration between three to seven days
Suffering from primary dysmenorrhea
Suffering from menstrual pain within the recent three consecutive months with a maximum VAS score of ≥4
Willing to sign the informed consent and comply with study procedure
|
|
| ExclusionCriteria |
| Details |
Diagnosis of secondary dysmenorrhea due to pelvic pathology, such as uterine fibroids, adenomyosis, endometriosis, or pelvic inflammatory diseases
Female who is lactating, currently pregnant, intention to become pregnant.
Current intrauterine device.
Patient taking regular NSAIDs for some therapeutic indication for pain relief other than menstrual pain.
Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies.
History of psychiatric disorder that may impair the ability of subjects to provide written informed consent
Metrorrhagia with menstrual cycles less than 21 days or oligomenorrhea with cycles over 40 days.
Oral contraceptives or other hormonal treatment use within the past three months.
Subject who is having allergic to ginger.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mean Change from baseline in
Maximum Dysmenorrheic Pain VAS Score
|
Day 0, Week 4, week 8
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean Change from baseline to end of trial in
oVMS
oSymptoms reported during menstruation (Low back pain, fatigue, nausea, headache, diarrhea, vomiting)
|
Day 0, Day 28, Day 56 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/02/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Primary dysmenorrhea is one
of the most prevalent gynaecologic disorders, affecting more than half of all
women of reproductive age. Symptoms of dysmenorrhea can be incapacitating and
women experiencing severe symptoms of dysmenorrheal are unable to engage in
normal activity and experience increased absence from school or work. Previous
studies have reported that the inhibition of COX-2 by nonspecific non-steroidal
anti-inflammatory drugs (NSAIDs) decreases prostaglandin synthesis,
contributing to their antipyretic and analgesic properties, and making them
effective for ameliorating the severity of menstrual pain in women. This study will evaluate the effect of standardised Ginger extract for the management of symptoms of Primary dysmenorrhea |