Clinical evaluation of Ayurvedic formulation in the Management of parikartika(Fissure in Ano)
- Conditions
- Health Condition 1: null- Patient of Anal fissure
- Registration Number
- CTRI/2017/06/008773
- Lead Sponsor
- CCRASNew Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 60
Patient of Fissure in Ano of either sex .
1)Patients of either sex aged 18 â??60 years.
2)Presence of Fissure in Ano
confirmed by DRE / proctoscopic
examination
3)Willing and able to participate for 06 weeks.
CLINICAL EVALUATION OF AYURVEDIC FORMULATION IN THE MANAGEMENT OF PARIKARTIKA (FISSURE IN ANO)
CASE REPORT FORM I â?? SCREENING
BEFORE TREATMENT
(Enter a ï?? in the appropriate box)
1.Centre Code: _____________
2.OPD No:_________________
3.Name of the Subject : _________________
4.Subject Sl. No.: _____________
5. Gender: Male (1) Female (2)
6.Age: __________years and __________ months
7.Date of birth
DD M M Y Y Y Y
8.Address:_______________________________________________________
_______________________________________________________
9.Telephone No: _______________________
10.Criteria for Inclusion Yes (1) No (0)
1)Patients of either sex aged 18 â??60 years.
2)Presence of Fissure in Ano
confirmed by DRE / proctoscopic
examination
3)Willing and able to participate for 06 weeks.
(For the inclusion â??YES to 1, 2 & 3â?? are compulsory)
11.Exclusion Criteria Yes (1) No (0)
1. Age below 18 years & above 60 years
2.Ulcerative colitis/Crohnâ??s disease
3.Patients of Malignancy/Tubercular/Syphilis/HIV/HbsAg/Bleeding disorders
4.Pregnancy and lactation
5.Patient who cannot report in person once in a week in the OPD
6.Patients with poorly controlled Hypertension( >160/100 mm Hg)
7.Patients with poorly controlled Diabetes Mellitus having HbA1C >8
8.Patients suffering from major systemic illness (Cardiac/Pulmonary/Hepatic/Renal disorders or any other conditions that may jeoparadise the study.
9.Alcoholics,Smokers and or drug abusers.
10.H/o hypersensitivity to any of the trial drugs or their ingredients.
11.Patients who have completed participation in any other clinical trial during the past six (06) months.
(For the Exclusion â??YES to any of the above)
Laboratory Examination:
ï??Haematology
oHaemoglobin : _____________________ g/dl
oT.L.C.: _____________________ / cu.mm.
oD.L.C. : N ____% E ____% B ____% L ____% M _____%
oBleeding time------------------- Clotting time----------------------
oProthrombin time------------------------------------------------------
oHIV 1 & 2----------------------------- VDRL--------------------------
oHBsAg--------------------------------------------------------------------
oE.S.R. : _________mm (at the end of 1st hour)
oBlood Sugar: Fasting ____________ mg/dl.
oBlood Sugar :Post Prandial--------------------------------
ï??Bio-chemistry:
oBlood Urea : _________________ mg/dL
oSerum
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relief in signs and symptoms of Fissure in AnoTimepoint: 42 days
- Secondary Outcome Measures
Name Time Method Reducing Resting Anal pressure,Reducing Anal inflammation,Healing the ulcer,Imroving Quality of Life and Improving Bowel movementTimepoint: 42 days