Phlai 2 capsules (compound D 8 mg) od evening after meal x 4 weeks

Phlai 1 capsules (compound D 4 mg) and placebo 1 capsule od evening after meal x 4 weeks

Placebo 2 capsules od evening after meal x 4 weeks

Allergic Rhinitis

Each capsule contains 4 mg compound D. Using orally in the evening everyday in 4 weeks

Phlai

Like Phlai capsule extract : :PVP K30, Calcium carbonate, Dibasic calcium phosphate, Sodium starch glycolate, Colloidal silicon dioxide, Ethanol 96%, Purified water, Magnesium stearate. Not having compound D. Using orally in the evening everyday in 4 weeks

Placebo oral capsule

Minh Phuoc Hoang, MD

"Efficacy and Safety of Phlai Capsule Compared to Placebo as the Treatment in Allergic Rhinitis Patients"

T5SS: (nasal obstruction, rhinorrhea, sneezing, itchy nose, itchy eyes). For each symptom:
0: no symptoms
mild
moderate
severe. Participants assess T5SS everyday. Self assessment twice a day Bedtime : reflective symptoms score Morning :instantaneous symptoms score. The mean score of two assessment is the T5SS. Investigator will calculate the mean T5SS in the follow up

This questionnaire is designed to find out how your health and well-being have been affected by rhinoconjunctivitis.

Use to measure nasal airflow during maximal inspiration

Outcome assessor in each site will check the three symptoms: nasal swelling, pale and nasal discharge by anterior rhinoscopy

Will plan to share information when finishing study

Principal Investigator

Chulalongkorn University

Government Pharmaceutical Organization

Participant in each arm will take medication provided by care providers who also do not know what kind of this medication

Participant, care provider and investigator, outcomes assessor in each site do not know what kind of medication in each package.

50 subjects with moderate knee osteoarthritis were supplied for four weeks with two tablets/day, each containing 350 mg of standardized extracts of Zingiber officinale and Acmella oleracea.

Pain

Osteo Arthritis Knee

Subjects were supplied for four weeks with two tablets/day and there was the evaluation of pain intensity, by a 30-days Visual Analogue Scale (VAS) and b) the assessment of knee function by Western Ontario and McMaster Universities Arthritis Index and by Tegner Lysholm Knee Scoring collected at baseline, at 15 and 30 days after treatment, Health-related quality of life, by the ShortForm36, inflammation by C-reactive protein and Erythrocyte Sedimentation Rate, body composition by dual-energy X-ray absorptiometry measured at baseline and 30 days after treatment.

Zingiber officinale and Acmella oleracea

Geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita - Azienda di Servizi alla Persona di Pavia

Zingiber and Acmella Against Knee Osteoarthritis

The Use of a New Food-grade Lecithin Formulation of Highly Standardized Ginger (Zingiber Officinale) and Acmella Oleracea Extracts for the Treatment of Pain and Inflammation in a Group of Subjects With Moderate Knee Osteoarthritis

Pain intensity measured both at motion and at rest, using the Visual Analogue Scale (VAS). VAS measures a characteristic or attitude ranging across a continuum of values and cannot be directly measured. For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. The results are showed with a scale 0-10. 0 means no pain and 10 high pain.

Assessment of knee pain by WOMAC (Western Ontario and McMaster Universities Arthritis) Index. The WOMAC pain scale consists of five questions that assess pain while walking on a flat surface, going up or down stairs, in bed at night, sitting or lying, and standing upright. The responses are recorded on a five-point Likert scale, with a higher score representing a greater level of pain. This scale is valid and reliable in hip and knee OA populations.

Tegner Lysholm Knee function Scoring (TLKS). Each patient completed a self-report questionnaire, TLKS, related to knee symptoms and function. It includes eight items: Limp, Support, Locking, Instability, Pain, Swelling, Stair climbing and Squatting. Each possible response to the items gives an arbitrary score on an increasing scale with a maximum of 100, a higher score representing a higher ability.

Health-related quality of life, recorded by the Short Form 36 Health questionnaire (SF-36), a generic measure of health status designed for use in population surveys which consider body pain as a dimension of health status. This is a self-reporting questionnaire and outcomes are measured with 8 numbers that express 8 different aspects of quality of life. Scoring 36-Item Health Survey is a two-step process. First, precoded numeric values are recoded per the given scoring key. all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores. Hence, scale scores represent the average for all items in the scale that the respondent answered.

Inflammation markers in plasma: C-reactive protein (CRP) (mg/dl). High-Sensitivity CRP was determined by immunonephelometry (mg/dl).

Body composition by dual-energy X-ray absorptiometry (DXA). Body composition was measured at baseline by DXA, using a Lunar Prodigy DEXA (GE Medical Systems, Waukesha, WI). Free Fat mass (Kg), Fat mass and visceral fat (Kg) data were derived from DXA using the DXA Prodigy enCORE software (version 17; GE Healthcare).

Inflammation markers in plasma: erythrocyte sedimentation rate (ESR) (mm). The erythrocyte sedimentation rate (ESR) was analyzed by capillary photometry (mm).

Azienda di Servizi alla Persona di Pavia

One-group pretest-posttest quasi-experimental design

The essential plai cream has anti-inflammatory and antimicrobial effects (Wasuwat1989, Giwanon 2000, Pithayanukul 2007, and Tripathi 2008). Active chemicals of plai cream are composed of sabinene, alpha and gamma tepinenes, terpinen 4-ol and (E)-1-(3,4-dimethoxyphenyl butadiene (DMPBD). The DMPBD has a property of anti-inflammatory activity(Ozaki 1991, Jeenapongsa 2003). Plavina® 40 mg in 100 gm (contains DMPBD of …%). This product was supplied in lacquered aluminum collapsible tube containing 100 gram cream packing.

Knee Osteoarthritis

Plavina cream

Department of Orthopedics, Faculty of Medicine, Khon Kaen University, Thailand

Faculty of Medicine KhonKaen University

Efficacy Study on Symptomatic Control of Patient With Knee Osteoarthritis Between 14% of Plai (Plaivana®) to Placebo Gels

The WOMAC score is a tri-dimensional, disease-specific, self-administered health status measure, probing clinically important, subject-relevant symptoms in the area of pain. The subject will answer WOMAC question on pain subscale, using the Linkert scale 0-100 at screening 1st visit to determine eligibility for inclusion in the study. The subject will complete the entire WOMAC questionnaire during visit 2-13 (week 1-12)

zingiber montanum/inflammation

"Efficacy and Safety of Phlai Capsule Compared to Placebo as the Treatment in Allergic Rhinitis Patients"

Zingiber and Acmella Against Knee Osteoarthritis

Efficacy Study on Symptomatic Control of Patient With Knee Osteoarthritis Between 14% of Plai (Plaivana®) to Placebo Gels

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