An open label clinical trial of an orally-dosed herbal formulation Zinova (Registered Trademark) for the prevention of dysmenorrhoea (menstrual pain).

An open label clinical trial of an orally-dosed herbal formulation Zinova (Registered Trademark) for the prevention of dysmenorrhoea (menstrual pain) in females with a normal menstrual cycle (28-32 days).

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000149864

Enrollment

Registered

2012-02-02

Start date

2010-04-01

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

This is a single-site, open-label short-term clinical trial with baseline data collection. Approximately 20 female participants aged between 18 and 45 years will be recruited from the CRO’s participant database and public media. Following initial screening via telephone, potential participants will attend the clinic for an information session and will be requested to provide their consent for inclusion in the trial. Consenting potential participants will undergo a medical assessment including lifestyle, current medications, physical examination, medical history, and menstrual history; this data will be used for the comprehensive screening and to provide contextual data for the study. The primary outcome measure is the pain VAS rating scales. The secondary outcome measure is analgesic use. The expected duration of the trial is five consecutive menses (approximately five months) for each participant. Baseline data will be collected during the first 2 menstrual cycles prior to intervention and for 3 months while on treatment.

Interventions

The investigational product is Zinova (Registered Trademark), a provisionally patented two piece capsule-form medication containing three chemically defined herbal extracts Terminalia chebula (300 mg), Curcumin BetaSorb (Registered Trademark) (100mg) and Zingiber officinale (80mg). The participants take 4 capsules/day (2 in the morning and 2 in the evening) for 3 months, commencing on day 1 of follicular phase of the menstrual cycle.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

Female Aged 18 to 45 Normal Menstrual Cycle 28-32 days for at least 6 months

Exclusion criteria

Irregular menstrual cycles Peri-menopausal Menopausal Chronic health problems- diabetes, heart disease, renal/liver disease Reproductive health problems - eg PCOS, endometriosis, Depression Pregnant Lactating Attempting pregnancy

Outcome results