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Complex Ayurvedic Treatment, Conventional Care

Phase 3

Osteoarthritis | Unknown | Musculoskeletal |Pulmonx Corporation|Last Updated: Mar 31, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment150

FDA Designations

No designations recorded

Clinical trial landscape

Complex Ayurvedic Treatment, Conventional Care · 1 trial · 1 indication

Phase 3 1
NCT01225133Complex Āyurvedic Treatment in Osteoarthritis of the Knee Compared to Standard Care.Osteoarthritis
COMPLETED150 Analytics
PHASE3COMPLETED
Complex Āyurvedic Treatment in Osteoarthritis of the Knee Compared to Standard Care.
OsteoarthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
week 12

Secondary Endpoints

Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Subscales
month 6
SF-36-questionnaire
week 12
POMS-questionnaire
week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Complex Ayurvedic TreatmentACTIVE_COMPARATORIn the Āyurveda arm treatment will be individualized according to the Āyurveda diagnosis and include manual treatments, massages, dietary advice, specific consideration of selected food items, nutritional supplements, āyurvedic lifestyle and yoga posture advice and daily self-applied knee massage.
Conventional CareACTIVE_COMPARATORPatients in the conventional standard care group will receive conventional standard care for OA of the Knee which includes self care advice, pain medication and intensified physiotherapy and follows the current international guidelines for OA of the knee.

Interventions

NameTypeDescription
Complex Ayurvedic TreatmentOTHERIn the Āyurveda group treatment will be individualized according to the Āyurveda diagnosis and include manual treatments, massages, dietary advice, specific consideration of selected food items, nutritional supplements, āyurvedic lifestyle and yoga posture advice and daily self-applied knee massage.
Conventional CareOTHERPatients in the conventional standard care group will receive conventional standard care for OA of the Knee which includes self care advice, pain medication and intensified physiotherapy and follows the current international guidelines for OA of the knee.
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Eligibility Criteria

Age Range40 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Male and female patients, * Age 40-70 years, * Prediagnosed, confirmed and documented diagnosis of OA of the knee. Diagnosis performed by a medical specialist (orthopedic surgeon, surgeon, radiologist) according to the American College of Rheumatology criteria, * Documented ra...

Countries:Germany
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Frequently asked questions about Complex Ayurvedic Treatment, Conventional Care

What is Complex Ayurvedic Treatment used for?

Complex Ayurvedic Treatment is an investigational therapy being studied for osteoarthritis, specifically osteoarthritis of the knee. It is a Phase 3 clinical-stage treatment that was evaluated in a completed trial in Germany. The treatment is being developed as a potential option for patients with this condition.

Who makes Complex Ayurvedic Treatment?

Complex Ayurvedic Treatment is being developed by Pulmonx Corporation, a company traded on the stock exchange under the ticker LUNG. The company conducted a Phase 3 clinical trial of this treatment for osteoarthritis of the knee. The trial was completed in Germany.

What phase is Complex Ayurvedic Treatment in?

Complex Ayurvedic Treatment is in Phase 3 clinical development for osteoarthritis. It is an investigational therapy, meaning it has not been approved by regulatory authorities. The Phase 3 trial, NCT01225133, has been completed, and the treatment remains under clinical investigation.

What clinical trials is Complex Ayurvedic Treatment in?

Complex Ayurvedic Treatment has one completed Phase 3 clinical trial, NCT01225133, titled 'Complex Āyurvedic Treatment in Osteoarthritis of the Knee Compared to Standard Care.' The trial enrolled 150 participants in Germany, with a minimum age of 40 years, and included both sexes. It was an active-controlled, randomized study.

Is Complex Ayurvedic Treatment the same as Conventional Care?

No, Complex Ayurvedic Treatment is not the same as Conventional Care. In the clinical trial NCT01225133, Complex Ayurvedic Treatment was compared against standard care as an active control. The study was designed to evaluate the Ayurvedic treatment relative to conventional care for osteoarthritis of the knee.