Evaluation of a Phyto Aromatherapy Treatment in the Management of Recurrent Cystitis (CYSTALTERNA)

Centre Hospitalier Universitaire de Nice

Status: Active, not recruiting

Conditions: Cystitis Recurrent

Treatments: Combination Product: CYSCONTROL/PHYTOCYST Herbal tea

Study type: Interventional

Funder types: Other

Identifiers

NCT04747041

17-AOIP-02

Details and patient eligibility

About

Half of the women have a once-in-a-lifetime episode of cystitis. Recurrence occurs in about 20% to 30% of patients, and half of these patients will have more than 4 episodes per year, defining recurrent cystitis.

The clinical assessment sometimes brings to light favourable factors; variables in pre- or post-menopause; but in the majority of cases, no explanatory cause can solve the problem and some authors refer to resignation as a classic reaction to this problem.

several countries have already opted for alternative treatments (Nonsteroidal anti-inflammatory drugs, phytotherapy, diuresis treatment), especially since the pressure of antibiotic selection is at the root of the dramatic spread of bacterial resistances.

There is a growing interest in the potential of complementary medicine to assist in this care. Products based on cranberries, for example, have been particularly studied and a 2012 Cochrane review concluded that there is a benefit with an estimated risk reduction of between 10 and 20%. Another "alternative" approach is the use of Chinese medicinal herbs. These herbs have been used for more than 2000 years.

The implementation of phyto-aromatherapy treatment implies a global management of patients with recurrent cystitis. Initially, it involves a curative phase as soon as the first symptoms of the attack appear, thanks to a mixture of antibacterial essential oils. In a second phase, it integrates a preventive phase over several months thanks to an association of medicinal plants whose effects in this field have been proven in vitro and in vivo, allowing to rebalance a "terrain" associating anxiety, hypersensitivity to pain, a terrain willingly associated with the irritable bowel syndrome in these patients. While having few side effects, the plants will act, in the long term, at different levels: directly on the cause of the disease thanks to their antiseptic, antiadhesive and diuretic activities, but also by reducing the symptoms thanks to their anti-inflammatory, analgesic, antispasmodic and anxiolytic activities.

Investigators hypothesize that patients with recurrent cystitis can be improved by a two-phase, multi-plant, phyto-aromatherapy treatment combining several plants: the treatment of attacks, by aromatherapy, and a prophylactic treatment, by phytotherapy. In the absence of any such studies published in the literature, investigators propose a non-randomised prospective monocentric interventional pilot study on 15 patients with proof of concept and feasibility.

Enrollment: 15 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women aged 18 or older.
• Affiliated to social security.
• Presenting recurrent cystitis defined by a frequency of at least 4 episodes per year.
• For women of childbearing age: effective contraception followed for at least 3 months prior to the start of the study and agreeing to keep it throughout the study period
• Available to consult a phyto-aromatherapy pharmacist for an initial consultation and then every 3 months (M3, 6,9, 12) and then at 18 months.
• Having been previously explored according to good practice and informed
• Having signed the informed consent

Exclusion criteria

• Pregnant or breastfeeding women
• Severe visceral deficiencies in the previous year.
• Individualised psychiatric pathology.
• Other progressive infectious pathologies requiring antibiotic treatment.
• Taking anticoagulants.
• Concomitant intake of non-drug treatments.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

15 participants in 1 patient group

Alternating each month for 1 year between Phytocyst herbal tea and Cyscontrol

Experimental group

Description:

Alternating each month (From Day1 to DAY15) for 1 year between Phytocyst herbal tea and Cyscontrol = Preventive Treatment In case of episode of cystitis : AROMAFEMINA, Capsules for the comfort of the urinary tract Oleocaps 2 : 2 capsules before meals, 3 times a day for 5 consecutive days.

Treatment:

Combination Product: CYSCONTROL/PHYTOCYST Herbal tea