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Clinical Trials/CTRI/2024/09/073613
CTRI/2024/09/073613Not yet recruitingPhase 2/3

A comparative clinical study between Raktamokshana and Physiotherapy in management of Katigraha- A randomized comparative clinical trial

Shree swaminarayan ayurvedic college1 site in 1 country40 target enrollmentStarted: October 1, 2024Last updated:
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Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
Katisula(Pain in the Back region)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study is an open-label randomized comparative clinical trial to evaluate the efficacy of Raktamokshana. A total 40 number of patients will be selected in the present study.  20-20 patients for each group. In trial group will do raktamokshna with modified shring yantra (cupping set) in the lumber region for twice a month (15 days interval) and its follow-up period is 2 months. In control group will do Physical physiotherapy in lumber region for once a day for 1 month and its follow-up period is 2 months. Clinical data obtained will be summarized at the end of the study. The conclusion will be made after the statistical analysis of the data.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 40.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Patients who are indicated (Yogya) for Raktamokshana.
  • •Age between 18 to 40 years.
  • •Subjects of either gender.
  • •Patients suffering from symptoms of, (Katisula)Pain in the Back region since 6 weeks (Katistambha)Stiffness in the Back region since 6 weeks Associated complaints, (Akunchana prasaran pravrutti savedana)Restricted movement since 6 weeks.

Exclusion Criteria

  • •Patients who are contraindicated ( Ayogya) for Raktamokshana.
  • •Uncontrolled other systemic disorders like Diabetes mellitus, Hypotension, etc.
  • •Subjects with congenital anomalies of the back region like spina bifida, vertebral stenosis, lumbarization, sacralization, lordosis, etc.
  • •Neuromuscular diseases like Myasthenia gravis, Muscular dystrophy, neuromyotonia, etc.
  • •Patient of any neurological disorders like sciatica etc.
  • •The patient also has osteoarthritis, osteoporosis, fracture, lumbar herniated disc, lumbar spinal stenosis, ankylosing spondylitis, etc.
  • •Female with gynecological disorders like uterine dysfunction and endometriosis and female in menstrual period and menopause.
  • •Patients suffering from serious blood disorders like Anemia & life-threatening diseases like HIV and HEPATITIS.
  • •Tuberculosis Malignancy Pregnancy RED FLAG warning signs require immediate or urgent evaluation, Cauda equina syndrome-Saddle anesthesia, Motor deficit at multiple levels, Urinary retention, Fecal incontinence Significant or progressive neurological deficits- Progressive motor weakness, Severe or incapacitating back or leg pain (e.g., requiring hospitalization, precluding walking, or significantly limiting activities of daily living) Cancer-History of cancer with new onset low back pain, Unexplained weight loss Vertebral infection-Fever, IV drug use, Recent infection Vertebral compression fracture or fracture due to acute injury-History of osteoporosis, Use of corticosteroids, Older age Inflammatory back pain- Morning stiffness lasting longer than 30 minutes (especially upon rising) in patients under age 40.

Outcomes

Primary Outcomes

Katisula(Pain in the Back region)

Time Frame: 1 Month

Katistambha(Stiffness in the Back region)

Time Frame: 1 Month

Secondary Outcomes

  • Akunchana prasaran pravrutti savedana(Restricted movement)

Investigators

Sponsor
Shree swaminarayan ayurvedic college
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Dhyankumar P Patel

Shree swaminarayan ayurvedic college

Study Sites (1)

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