Evaluation of efficacy and safety of Ayurvedic drug formula in painful menstruation

Evaluation of the efficacy & safety of Zandu Ovoutoline Forte Tablet and Zandu Ovoutoline Syrup in the management of Dysmenorrhea: A Post Marketing study - nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/08/093902

Enrollment

200

Registered

2025-08-29

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N00-N99- Diseases of the genitourinary system

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age- 18 years- 45 Years 2. Painful menstruation for at least 3 consecutive cycles without any clinical pathology. 3. Associated with or without Leucorrhea. 4. Associated with or without excessive bleeding in amount or duration or both. 5. Patient willing and able to give written consent to participate in the trial.

Exclusion criteria

Exclusion criteria: 1. Patient below age 18 years and above 45 years. 2. Pregnant or Lactating women. 3. Patient coming with complaint of Hypomenorrhea or Oligomenorrhea. 4. Patient having any pelvic pathology like uterine fibroid, polyp, Ovarian Cyst, endometriosis etc. 5. Patient having associated complaints of any serious systemic disorders like DM, HTN and cardiac disorders etc. 6. Known case of malignancy of pelvic organs. 7. Patient having abnormal (excessive) vaginal discharge being a known case of neoplasmic changes, cervical intraepithelial neoplasia or cervical carcinoma. 8. Women using an IUD or Oral Contraceptive Pills (OCP). 9. Patient with known cases of AIDS, HIV, and STDs, severe Anaemic (Hb less than 8 gm), and immune-compromised state. 10. Patients who received antifungal or antimicrobial therapy (systemic or intra-vaginal) in the previous month before the screening. 11. Patient who has a history of hypersensitivity to the trial drug or any of its ingredients. 12. Patient who completed participation in any other clinical trial during the past two months. 13. Other debilitating neurological or psychiatric disorders.

Design outcomes

Primary

Measure	Time frame
1. To evaluate the efficacy & safety of Zandu Ovoutoline Forte Tablet and Zandu Ovoutoline Syrup in the management of Dysmenorrhea. 2. To compare the efficacy of Zandu Ovoutoline Forte Tablet and Zandu Ovoutoline Syrup in the management of Dysmenorrhea. Timepoint: 4 weeks	—

Secondary

Measure	Time frame
1.To study the etiopathogenesis of Dysmenorrhea with other associated menstrual disorders like leucorrhea & menorrhagia if present. 2. To validate the clinical efficacy of Zandu Ovoutoline Forte tablet & Zandu Ovoutoline Syrup on the basis of scientific parameters in the management of Dysmenorrhea. 3. To evaluate the safety of Zandu Ovoutoline Forte tablet & Zandu Ovoutoline Syrup on the basis of scientific parameters in the management of Dysmenorrhea. 4. To assess the effect, safety & tolerability of Zandu Ovoutoline Forte tablet & Zandu Ovoutoline Syrup based on adverse events, laboratory parameters, & vital signs. Timepoint: 90 days	—

Measure

Time frame

1.To study the etiopathogenesis of Dysmenorrhea with other associated menstrual disorders like leucorrhea & menorrhagia if present. 2. To validate the clinical efficacy of Zandu Ovoutoline Forte tablet & Zandu Ovoutoline Syrup on the basis of scientific parameters in the management of Dysmenorrhea. 3. To evaluate the safety of Zandu Ovoutoline Forte tablet & Zandu Ovoutoline Syrup on the basis of scientific parameters in the management of Dysmenorrhea. 4. To assess the effect, safety & tolerability of Zandu Ovoutoline Forte tablet & Zandu Ovoutoline Syrup based on adverse events, laboratory parameters, & vital signs. Timepoint: 90 days

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Countries

India

Contacts

Public ContactDr Shikha Sharma

State Ayurvedic College and Hospital Lucknow

drshikhasharma1982@gmail.com8743976379

Outcome results