To evaluate the effect of herbal pain killer in the management of pain full periods

Phase 2

Completed

• Conditions: Health Condition 1: N944- Primary dysmenorrhea

• Registration Number: CTRI/2018/02/012102
• Lead Sponsor: Dabur India Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2010-10-15
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1. Female in the reproductive age group

2. Females presenting with Dysmenorrhea with or without any of the following symptoms associated with mensturation:

a. Any kind of pain: headache, 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 study and come for regular follow up as and when required

4. Readiness to sign Informed Consent Form

Exclusion Criteria

1. Patients having organic causes of pain and menstrual abnormalities like uterine myeloma, adenomyosis, polyps, fibroids, endometriosis

2. Patients suffering from systemic or metabolic disorders like pituitary disease, diabetes mellitus, thyroid dysfunction and coagulation disorders

3. Patients having any other kind of chronic disease like respiratory or cardiac problems, HIV

4. Subjects not willing to sign Informed Consent Form

5. Patients participating in any other clinical study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relief from dysmenorrhea and other related symptoms associated with menstruationTimepoint: Baseline(Day 0), Visit 1(Day 1), Visit 2(Day 3) & Visit 3(Day 17)

Secondary Outcome Measures

Name	Time	Method
Overall safety of the subjects throughout the study periodTimepoint: Baseline(Day 0), Visit 1(Day 1), Visit 2(Day 3) & Visit 3(Day 17)