Clinical study to Evaluate the Efficacy, Safety and Tolerability of an Ayurvedic Formulation in the management of Primary Dysmenorrhea in Female Adults.

Not Applicable

Completed

• Conditions: Health Condition 1: N944- Primary dysmenorrhea

• Registration Number: CTRI/2014/04/004530
• Lead Sponsor: Ms Cavinkare Research Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

1.Healthy women ages 18-40 (both ages inclusive) with a history of Primary Dysmenorrhea (onset of symptoms < 12 months after menarche).

2. Regular menstrual cycles for atleast 6 months (once in 28-35 days with each cycle lasting a minimum of 3 days.)

3.Subjects with body mass index of 18.50 to 30.00 kg/m2 (Both values inclusive)

4. Subjects who score either â??Moderateâ?? or â??Severeâ?? in the Severity Assessment during Visit 0.

5.Subjects who understand the nature and purpose of the study and who are willing to comply with study procedures.

Exclusion Criteria

1.Known or suspected secondary dysmenorrhea (major abdominal or pelvic surgery, endometriosis, salpingitis, pelvic inflammatory disease (PID), ovarian cysts, pathological vaginal secretion, chronic abdominal pain, inflammatory bowel disease, irritable bowel syndrome).

2.Concomitant treatment with oral contraceptives, Gonadotrophinreleasing hormone agonists and antagonists, antiandrogens, gonadotropins, antiobesity drugs.

3.Recent history of abdominal surgery in the last 6 months.

4.Unevaluated gynecological abnormalities inclusive of oncological diagnosis or suspicion (unexplained vaginal bleeding, cervical dysplasia)

5.Gross developmental defect or congenital abnormalities of uterus

6.Patients with uncontrolled hypertension, diabetes or other uncontrolled co-morbidities.

7.Pregnant & nursing women or women who have given birth or had a miscarriage within the last 6 months.

8.Women who have undergone hysterectomy.

9.Any history of major systemic illness and significant gastrointestinal & liver disorders, renal disorders, endocrine abnormalities, cardiovascular, respiratory, neuropsychiatric disorders or any other significant medical illness, in view of the investigator.

10.Perimenopausal and Menopausal women.

11.Known or suspected hypersensitivity to herbal products.

Study & Design

• Study Type: Interventional
• Study Design: Not specified