Add-on Complex Ayurvedic Treatment in Fibromyalgia-Syndrome Compared to Standard Care Alone

Kontrollierte Klinische Nicht-randomisierte Pilotstudie Zur Komplexen Āyurveda-Therapie Beim Fibromyalgiesyndrom im Vergleich Zur Konventionellen Standardbehandlung

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01389336

Acronym

KAFA

Enrollment

Registered

2011-07-08

Start date

2011-07-31

Completion date

2013-05-31

Last updated

2013-05-08

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

Conditions

Fibromyalgia Syndrome

Keywords

Fibromyalgia Syndrome, Fibromyalgia, Ayurveda, Traditional Indian Medicine, CAM, Pain, Chronic Widespread Pain

Brief summary

The aim of this study is to evaluate the effectiveness of an additive complex āyurvedic diagnosis and treatment compared to conventional standard care alone in stationary patients with Fibromyalgia Syndrome.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* informed consent * age between 18 and 70 years * FMS according to current guidelines

Exclusion criteria

* change of pharmacological FMS treatment \>= 6 weeks before inclusion * pregnancy or breat feeding * acute psychiatric condition * severe acute somatic disease * severechronic comorbidity * obesity WHO \>= II degree * bloodcoagulation-disease * intake of opiods * current treatment with hyperthermia * simultaneous participant in other trial * praticipation in other trial during 6 month before inclusion

Design outcomes

Primary

Measure	Time frame	Description
Fibromyalgia Impact Questionnaire (FIQ)	max. 3 weeks	Change in FIQ after completion of IPD-treatment

Secondary

Measure	Time frame
State Trait Anxiety Inventory (STAI)	max. 3 weeks
Profile of Mood States (POMS)	max. 3 weeks
Short Form 36 Health Survey (SF-36)	max. 3 weeks
Functional Hanover Questionnaire (FFBH)	max. 3 weeks
Likert-Scales	max 3 weeks
FIQ	6 month
FFBH, STAI, POMS, SF-36, VAS, Likert-Scales.	6 month
VAS for pain	max 3 weeks

Countries

Germany

Outcome results