Clinical Evaluation of Safety & efficacy of Mensta (WHS/2004/1) in Menstural Cramps.
- Conditions
- Health Condition 1: N945- Secondary dysmenorrhea
- Registration Number
- CTRI/2018/03/012629
- Lead Sponsor
- Dabur India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
1. Patients aged between 15-45 years (females in the reproductive age group).
2. Females presenting with DYSMENORRHEA with or without any of the following
symptoms associated with menstruation
a. Any kind of pain like headache, backache abdominal pain,bodyache
b. Nausea and vomiting
c. Weakness
d. Psychological symptoms- like anxiety, stress, depression, irritability,
restlessness
e. Irregular cycles
3. Willingness to participate in the trial and to come for regular follow up as and when
required.
4. Readiness to sign Informed Consent Form
1. Patients nursing or pregnant women.
2. Patients having organic causes of pain and menstrual abnormalities like uterine
myeloma, adenomyosis, polyps, fibroids, endometriosis etc.
3. Patients suffering from systemic or metabolic disorders like pituitary disease,
diabetes mellitus, thyroid dysfunction and coagulation-disorders.
4. Patients having any other kind of chronic disease like respiratory or cardiac
problems, HIV.
5. Subjects not willing to sign informed consent.
6. Patients participating in any other clinical study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relief from symptoms of DysmenorrheaTimepoint: Evaluations were done at 2 week intervals for 12 weeks
- Secondary Outcome Measures
Name Time Method ilTimepoint: Nil