A Single Centric, Open Label, Non-Randomized, Phase IV Post Marketing Surveillance Study to Evaluate the Efficacy and Safety of Product Sachi Saheli in order to improve the quality of life during the menstruation cycle

A Single Centric, Open Label, Non-Randomized, Phase IV Post Marketing Surveillance Study to Evaluate the Efficacy and Safety of Product Sachi Saheli in order to improve the quality of life during the menstruation cycle in female subjects of 13 to 45 years of age

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2021/07/034539

Enrollment

120

Registered

2021-07-02

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: N946- Dysmenorrhea, unspecified

Interventions

Intervention1: Sachi Saheli: Oral administration of 10 ml syrup twice a day after meal, preferably morning and evening. 1 tablet twice a day orally after meal, preferably morning and evening Control I

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age between 13 to 45 (Female subjects only) 2. Subjects suffering from Dysmenorrhea and/or Leucorrhea 3. Willingness to take part in study and able to attend all scheduled visits 4. Subjects suffering from issues like loss of appetite, anemia, general weakness and period irregularities

Exclusion criteria

Exclusion criteria: 1. Pregnant, breast-feeding, subjects undergone any surgery and else taken part in any clinical trial 2. Not willing to sign the ICF or give the consent

Design outcomes

Primary

Measure	Time frame
1. To evaluate the increase in blood hemoglobin level in female subjects as compared to baseline. 2. To determine the total number of subjects with symptomatic relief of lower back pain, leucorrhea and general weakness assessed through Investigator Assessment Questionnaire and Subjective Assessment Questionnaires. Timepoint: Day 1- day 90	—

Secondary

Measure	Time frame
1. To assess the safety of investigational product Sachi Saheli. 2. Incidence of adverse events reported or observed during the study period. Timepoint: Day 1-day 90	—

Countries

India

Contacts

Public ContactMr Hasan Ali Ahmed

Divisa Herbal Care

vijaykimtata.vk@gmail.com9816333352

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026