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Clinical Trials/CTRI/2022/05/042949
CTRI/2022/05/042949Not yet recruitingNot Applicable

Effectiveness of individualized homoeopathic medicines in treatment of urolithiasis patients on health-related quality of life : A single group, pre-post interventional study

SABA NISAT BANU1 site in 1 country50 target enrollmentStarted: May 31, 2022Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
Improvement of each case will be assessed by using USS score index. This scale will help to assess or compare the outcome of the treatment with gradation in particular level. On the basis of the score obtained from this chart, the intensity of the cases will be grouped into mild(1-7), moderate (8-14) and severe (15-22)

Study Overview

Brief Summary

Urolithiasisis the third most common disease of urinary tract. Thisdisease affects about 12% of the whole mankind at some stage intheir lifetime. Therecurrence rate of renal stone between men and female in Asia is 2:1. This condition has been gradually lower downthe kidney function and associate with an increase rick of chronic kidneydisease and even end stage renal disease and majorityof cases are treated by surgical intervention.  So,it consider as a major social and economic problem. Beside this the recurrencerate is also high, and prevention of this recurrence remains to be a serioushealth issue as it requires better understanding of mechanism involve in stoneformation.

RESEARCHQUESTION : Doesindividualhomeopathic medicine produces significant effects in health relatedquality oflife in cases of  urolithiasis?

HYPOTHESIS:

NULLHYPOTHESIS (H0):

Individualizedhomoeopathicmedicine has no role in management of pain and removing of stones in cases ofuncomplicated renal stone.

Individualizedhomoeopathicmedicines has no role in improvement of health related  quality of life among such patients

ALTERNATIVEHYPOTHESIS (HA):

Individualizedhomoeopathicmedicine has role in management of the pain and removing of the stones in casesof uncomplicated renal stone.

Individualizedhomoeopathicmedicine has role in improvement of health related  quality of life  among such patients

Study Design

Study Type
Interventional
Allocation
Not Applicable
Masking
Not Applicable

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1.Patients who are diagnosed with renal stone by USG and/or Xray.
  • All sex, of all religions and of all different socio economic status 3.Patients willing to give written consent for participation.

Exclusion Criteria

  • Patients with gross pathological changes like CA, chronic kidney disease, kidney failure, hydronephosis.
  • Suffering from systemic diseases like Cardiovascular disease, Hepatobiliary disease, Endocrinal disease
  • Insane, non-co-operative patient
  • Stag horn calculi, calculi in pole of kidney
  • Acute retention of urine for more than 24 hours
  • Any developmental or congenital anomaly of kidney
  • Pregnant and lactating mother.

Outcomes

Primary Outcomes

Improvement of each case will be assessed by using USS score index. This scale will help to assess or compare the outcome of the treatment with gradation in particular level. On the basis of the score obtained from this chart, the intensity of the cases will be grouped into mild(1-7), moderate (8-14) and severe (15-22)

Time Frame: Follow up will be done on baseline and each follow up at an interval of 4 weeks and sonography at base line and after 3 months

Reduction of stone size and also removal of stone will be confirmed by USG reports and x-ray reports.

Time Frame: Follow up will be done on baseline and each follow up at an interval of 4 weeks and sonography at base line and after 3 months

Secondary Outcomes

  • Improvement of the general health related quality of life will be assessed by WISQOL scale(Followed will be done on baseline and each followup at an interval of 4 weeks)

Investigators

Sponsor
SABA NISAT BANU
Sponsor Class
Other [self]

Study Sites (1)

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