Randomized control clinical study to evaluate the efficacy of Arshoghnivarti and Corect Suppository in Hemorrhoids.

TITLE- ARANDOMIZED CONTROL CLINICAL STUDY TO EVALUATE THE EFFICACY OF ARSHOGHNIVARTIAND CORECT SUPPOSITORY IN HEMORRHOIDS.

Research  Question :-

Is Arshoghnivarti more effective than Corectsuppository in hemorrhoids.

 Hypothesis –

Arshoghnivarti is moreeffective than Corect suppository in hemorrhoids.

 NullHypothesis

**(Ho) :-**Arshoghanivarti is as effective as Corect suppository in hemorrhoids.

 Alternate Hypothesis

**(H1) :-**Arshoghnivarti is moreeffective than Corect suppository in hemorrhoids.

 (H2) : - Arshoghnivarti is less effective than Corect suppository in hemorrhoids.

Rationale:-

1. Nowadays fast foods,sedentary lifestyles, irregularity in meals etc. have lead to impairment ofgastrointestinal system. This has lead to an increase in diseases of thegastrointestinal tract. One of the major groups of these diseases are theano-rectal diseases.

2)According to Indianjournal of surgery the incidence of hemorrhoids is 72% and prevalence rate 38.93%As far as the treatment of hemorrhoids is concerned use of laxatives andsurgical therapy is by far the choice of treatment in modern medicine. Surgeryis costly and post operative morbidity is frequently seen.

3)Ayurveda offers enteralas well as local therapies for Arsha. In addition to this various surgical andpara surgical procedures are also mentioned. A lot of work has been done onarsha. But local drug therapy, its action on local anal mucosa needsexploration. One such refrence is mentioned in BhaishajyaRatnawali.

   This reference of Arshoghnivartiseems like an effectivelocal treatment option in hemorrhoids. Ghoshatak or koshataki is ruksha, katu,pachan as well as virechak. This gunas of koshataki may help in thesampraptibhanga of arsha disease2. Also it is mentioned as a drugwhich can be used in Arsha in the Nighantus.

Keeping this in mind this study is planned.

Drug review –

A) Trial drug=-

Arshoghnivarti (Suppository) Contents -1

Ghoshatak (Luffaactuangula var.)

Guda (Jaggery) – as a binding agent.

Drugs will be procured from authentic sources. Authentication andstandardization will be done.

Final product will be standardized.

B) Control Drug-

Corect suppository-merd  meridian labs

Contents-

Allantoin-0.5% w/w

Hydrocortisone – 0.25% w/w

Lidocain -3% w/w

Zinc oxide-5% w/w

AIM AND OBJECTIVES:-

Aim**:****-**

To evaluate and compare the efficacy of Arshoghnivarti and Corect suppository on hemorrhoids.

Objectives:-

Primary objective -

To evaluate the efficacy of Arshoghnivarti againstCorect suppository in Hemorrhoids.

 Secondary objective -

To study adverse effects of Arshoghnivarti and ofCorect suppository if any.

Materials and Methodology –

Materials -

1. Patients :

Selection Of patients –

Patients diagnosed with hemorrhoids fulfilling the inclusion criteria’swill be selected from subjects coming in the Out patient Department (OPD) andpatients admitted in the in patient department (IPD) of the Ayurvedic hospital.

This study is aimed at completing 100 patients.

2. Drug – Drug will be standardized.

Methods ofStandardization:

A) Raw material - As perPharmacopeial(API) guidelines:

B)  IPQC (In process quality control) – As perGMP:

C)Finished productstandardization – As per Pharmacopeia Guidelines.

Diagnostic criteria of patients :-

1)Signs and symptoms of hemorrhoids.

2)Per Rectal examination

3. Proctoscopy

GROUPING OF PATIENTS-

GROUP A

GROUP B

|Drug

Arshoghnivarti(suppository) along with concomitant oral treatment and dietetic advice.

Corect suppository

along with concomitant oral treatment and dietetic advice.

|Dosage

1 suppository per rectally twice a day.

suppository will be inserted by lubricating with Ghruta.

 1 suppository per rectally twice a day.

|Route of administration

Per rectal

Per rectal

|Duration

15 days

15 days

Study design -

Prospective  randomized control clinicalstudy

 Screening of patients for diagnosis and inclusion

 Initial assessment

 Randomization (lottery method)andGroupallocation

**1.Group A :(**50Patients)-

Arshoghnivarti (suppository) per rectally twice a day for 15 days.

**2. Group B:(**50Patients)-

Corect suppository per rectally twice a day for 15 days.

  Follow up on day 7 of treatment and on completion of treatment 15thday will be taken.

Observations

 Statisticalanalysis

Conclusion

Durationof study–  15 days

 Sample size – According to statistics n = 100.

n =Z2pq/e2

z- constant= 1.96

p= prevanlace9=38.93%-

q=1-p

e= standard error= 10-15%

Considering a drop out of30% minimum 130 patients will be enrolled in the study. This study is aimed atcompleting 100 patients.

Data collection methods –A case record form is prepared for detailed data collection. Data will becollected according to the case proforma.

Consent – Informed writtenConsent will be obtained prior to the trial from each patient.

CRI TERIA  FOR ASSESSMENT

SubjectiveParameters:-

1)     Bleeding per rectum

2)     Pruritisani

3)     Pain

4)     Tone of anal sphincter.

 ObjectiveParameter8:-

Degree of Hemorrhoids

 SUBJECTIVEPARAMETER GRADATION:-

1.     P/Rbleeding Grade –

1st grade – 0- 5 drops.

2nd grade – 6 – 15 drops.

3rd grade – more than 15 drops.

 2.     Pain–

will be assessed using VAS scale with 0 - 10score.

 3.     PruritisAni–

will be assessed using VAS scale with 0 - 10 score

 4.   Tone of anal sphincter-

DRESS (  Digital Rectal Examination scoring System)10-  0-5

0- No discernable pressure

3- normal tone

5- Extremely tight sphincter

OBJECTIVEPARAMETERGRADATION –

Degree of Hemorrhoids –

1st degree Hemorrhoids-  Hemorrhoids projecting slightly in the lumenof anal canal, no prolapse.

2nd degree Hemorrhoids– Hemorrhoidsprolapse out of he anus while defecation but return spontaneously to the analcanal when defecation ceases.

3rd degreeHemorrhoids– Hemorrhoidsprolapse out of he anus while defecation but return manually to the anal.

STATISTICAL ANALYSIS

All observed data collected after the finalassessment will be subjected to suitable statistical analysis. The Quantitativedata will be analyzed by Statistical Z test and t test paired for within thegroups and unpaired for between the groups for overall benefits. Qualitativedata will be analyzed with Wilkosons test.

  DISCUSSION:

 The observed results in both the groups willbe compared and the differences and effects will be discussed. Adverse effectsif any observed will be discussed.

 CONCLUSION:-

 Conclusion will be drawn based on overallassessment, tabulation, statistics and graphic presentation of the data.

 SUMMARY-

The comparative clinical study will besummarized in brief after completion of the study.