Add-on Complex Ayurvedic Treatment in Fibromyalgia-Syndrome NCT01389336

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT01389336
Other study ID #	KAFA
Secondary ID
Status	Completed
Phase	N/A
First received	July 6, 2011
Last updated	May 7, 2013
Start date	July 2011
Est. completion date	May 2013

Study information
Verified date	May 2013
Source	Charite University, Berlin, Germany
Contact	n/a
Is FDA regulated	No
Health authority	Germany: Ethics Committee
Study type	Observational

Clinical Trial 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.

Recruitment information / eligibility
Status	Completed
Enrollment	31
Est. completion date	May 2013
Est. primary completion date	May 2013
Accepts healthy volunteers	No
Gender	Both
Age group	18 Years to 70 Years
Eligibility	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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country	Name	City	State
Germany	Immanuel Hospital Berlin	Berlin

Sponsors *(2)*
Lead Sponsor	Collaborator
Andreas Michalsen	Dr.Heinz Horst Deichmann Foundation,Essen,Germany

Country where clinical trial is conducted

Germany,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	Fibromyalgia Impact Questionnaire (FIQ)	Change in FIQ after completion of IPD-treatment	max. 3 weeks	No
Secondary	Functional Hanover Questionnaire (FFBH)		max. 3 weeks	No
Secondary	State Trait Anxiety Inventory (STAI)		max. 3 weeks	No
Secondary	Profile of Mood States (POMS)		max. 3 weeks	No
Secondary	Short Form 36 Health Survey (SF-36)		max. 3 weeks	No
Secondary	VAS for pain		max 3 weeks	No
Secondary	Likert-Scales		max 3 weeks	No
Secondary	FIQ		6 month	No
Secondary	FFBH, STAI, POMS, SF-36, VAS, Likert-Scales.		6 month	No

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT05933486` - Efficacy and Safety of Tongluo-Kaibi Tablet in Patients With Fibromyalgia Syndrome	Phase 4
Completed	`NCT01642810` - Online Acceptance-based Behavioural Treatment for Fibromyalgia	Phase 3
Completed	`NCT00757679` - Evaluation of the Antinociceptive and Analgesic Effects of Milnacipran	Phase 2
Completed	`NCT00757731` - FMS European Long-Term Study	Phase 3
Completed	`NCT01968772` - Effect of Transdermal Magnesium Chloride on Quality of Life in Patients With Fibromyalgia	N/A
Completed	`NCT00401830` - Assessing Efficacy and Safety of Lacosamide Compared to Placebo in Reducing Signs and Symptoms of Fibromyalgia Syndrome.	Phase 2
Completed	`NCT04517929` - Effectiveness of Group Psychotherapy in Patients With Fibromyalgia Syndrome	N/A
Completed	`NCT06285045` - Study on Roujin Formula in the Treatment of Fibromyalgia Syndrome With Blood Deficiency and Liver Depression	N/A
Active, not recruiting	`NCT03844412` - Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments	Phase 2
Completed	`NCT02800720` - Meditation Awareness Training for the Treatment of Fibromyalgia Syndrome	N/A
Not yet recruiting	`NCT01465477` - Influenza Vaccination in Fibromyalgia Patients	N/A
Completed	`NCT00528710` - Efficacy of S-Adenosylmethionine in Fibromyalgia	Phase 2
Completed	`NCT00447083` - Benefits of Tanning in Fibromyalgia Patients	N/A
Not yet recruiting	`NCT06147882` - The Effect of Positive Psychotherapy Based Psychoeducation on Pain Perception With Fibromyalgia Syndrome	N/A
Completed	`NCT05381012` - Fibromyalgia Syndrome on Patients With Chronic Migraine	N/A
Completed	`NCT00464737` - The Use of Rotigotine for Treatment of Reducing Signs and Symptoms of Fibromyalgia in Adults.	Phase 2
Completed	`NCT04426864` - Efficacy of Different Types of Exercises in Women With Fibromyalgia Syndrome.	N/A
Completed	`NCT02881411` - Self Soft Tissue Therapy for Fibromyalgia Syndrome	N/A
Not yet recruiting	`NCT01147263` - Palpitations and Tachycardia in Fibromyalgia Syndrome	N/A
Completed	`NCT00222274` - HRV Biofeedback in Fibromyalgia	N/A

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

Clinical Trial Details — Status: Completed

Administrative data

Study information

Clinical Trial Summary

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Locations

Sponsors (2)

Country where clinical trial is conducted

Outcome

External Links