Herbal Medication to Treat Dry Eye in Peri/ Post-menopausal Women
Dry Eye
About this trial
This is an interventional treatment trial for Dry Eye focused on measuring Menopausal women, Herbal treatment, Quality of Life, eicosanoids, cytokines
Eligibility Criteria
Inclusion Criteria:
- Age 40-79 years old women
- Peri and Post-menopausal women
- Chief complaint of participant should be consistent with dry eye symptoms based on SPEED Questionnaire, with a score of > 6 (Appendix 5)
History of presenting TCM score symptoms:
4.1. TCM dry eye assessment score (Appendix 3) The pattern deviation can be determined if 3 or more main symptoms are present (one of which is a localized eye symptom and one of which is a system symptom), together with at least one accompanying symptom.
4.2 Liver-Kidney yin deficiency assessment score (Appendix 4) This form is to determine the extent of Liver-Kidney Yin Deficiency (assessed at SCHMI).
Any score<14 will not satisfy the criterion for Liver Kidney Yin Deficiency and will not be recruited. This detailed TCM score will also be a secondary outcome measure in the analysis of pre/post herbal treatment (see below).
Clinical signs:
5.1. Tear break up time (TBUT) ≤10s or Schirmer I test ≤10mm/5 mins
- Normal renal and liver function at baseline, i.e., all parameters within the reference value
Exclusion Criteria:
- Currently or intention to use hormonal therapy (eg. cancer patients who is on tamoxifen)
- Currently pregnant or breastfeeding
- Hysterectomy procedure done previously
- Removal of cysts or polyp procedure done previously
- Requirement to wear contact lens, and having worn such lenses in week preceding eligibility
- Glaucoma, significant cataract, age related macular degeneration or other ophthalmic disease, eg. Extraocular muscle palsies, facial paralysis, ectropion, entropion, trichiasis
- Requirement of any eyedrops other than artificial tears.
- Previous eye surgeries including LASIK (within 6 months) or punctal plugs in-situ
- Autoimmune systemic diseases: Steven-Johnson syndrome, Sjogren's syndrome, Rheumatoid Arthritis, Lupus
- Systemic disease requiring regular medication (except hypertension and lipidemia)
Sites / Locations
- Singapore National Eye CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Active herbal capsules
Placebo capsules
Wei's Qi Ju Gan Lu Formula is a herbal formulation initiated by the senior TCM collaborator, Prof Wei QP. This TCM formulation is prescribed to treat the dry eye patients with "liver-kidney yin deficiency". The treatment regulation aims to nourish the Liver and Kidney, enrich yin deficiency, in order to promote tears production, hence treatment of Dry Eye.
Placebo capsule which contains 0.5g maltodextrin without any herbs medicine.