CTRI/2022/02/039897
Not yet recruiting
未知
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
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: K928- Other specified diseases of the digestive system
- Sponsor
- Olene Life Sciences Private Limited
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy Female subjects 18 â?? 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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Not yet recruiting
Not Applicable
A Clinical Study to Evaluate the Safety and Efficacy of OLNP-27 versus placebo in Reducing Symptoms of Knee OsteoarthritisCTRI/2022/01/039859Olene Life Sciences Private Limited
Completed
Phase 3
I4V-MC-JAIASystemic Lupus ErythematosusJPRN-jRCT2080224034Eli Lilly Japan K.K.750
Recruiting
Phase 3
A Study of 2 Doses of MAP0010 and Placebo in Asthmatic ChildreCTRI/2011/091/000069MAP Pharmaceuticals, Inc.360
Not yet recruiting
Phase 3
Efficacy and Safety evaluation of OLNP-06 in Subjects with Functional Dyspepsia.CTRI/2019/09/021019Olene Life Sciences Private Limited
Active, not recruiting
Phase 3
Phase III Study to Compare the Efficacy and Safety of Acotiamide 100 mg Tablets with Placebo in Patients with Functional Dyspepsia.CTRI/2015/02/005557PIN Limited222