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Clinical Trials/CTRI/2022/10/046928
CTRI/2022/10/046928Not yet recruitingPhase 2

Clinical evaluation of effects of Hijama- Bila- Shurt (Dry Cupping) as a part of multimodal approach in the management of fibromyalgia.

Ajmal Khan Tibbiya College1 site in 1 country60 target enrollmentStarted: May 11, 2022Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Improvement Criteria- it will be correlated with the subjective and objective parameters.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Clinical evaluation of effects of Hijama- Bila- Shurt  (Dry Cupping) as a part of multimodal approach in the management of  fibromyalgia.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Open Label

Eligibility Criteria

Ages
20.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •1.Clinically Diagnosed patient of FMS (Based on 2016 revision of American College of Rheumatology (ACR) Diagnostic Criteria of 2011/
  • •2.Patients who are able to give written informed consent and follow the protocol of study.
  • •3.Patients of either sex 4.Patients in age group of 20-60 years.

Exclusion Criteria

  • •1.Patients below 20 years and above 60 years
  • •Primary generalized osteoarthritis, polymyalgia rheumatica, Rheumatoid arthritis, Diabetic Neuropathy,Hypothyroidism Pregnant and Lactating women
  • •Patients with uncontrolled diabetes and severe hypertension.
  • •5.Patient taking medicine for any other psycho- somatic disorders.
  • •6.History of trauma.
  • •7.Patients having anemia(Hb% less than 9gm%).
  • •8.Patients unable to give informed written consent.

Outcomes

Primary Outcomes

Improvement Criteria- it will be correlated with the subjective and objective parameters.

Time Frame: Every 14th day for 28 days

1.Primary Parameters

Time Frame: Every 14th day for 28 days

•NRS (Numeric Rating Scale)

Time Frame: Every 14th day for 28 days

0-no pain to 10-worst possible pain

Time Frame: Every 14th day for 28 days

Secondary Outcomes

  • 2.Secondary Parameters:(1.Revised Fibromyalgia Impact Questionaire(FIQR))

Investigators

Sponsor
Ajmal Khan Tibbiya College
Sponsor Class
Research institution and hospital

Study Sites (1)

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