Health Condition 1: null- Patient of Anal fissure
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 D D 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 o Haemoglobin : _____________________ g/dl o T.L.C.: _____________________ / cu.mm. o D.L.C. : N ____% E ____% B ____% L ____% M _____% o Bleeding time------------------- Clotting time---------------------- o Prothrombin time------------------------------------------------------ o HIV 1 & 2----------------------------- VDRL-------------------------- o HBsAg-------------------------------------------------------------------- o E.S.R. : _________mm (at the end of 1st hour) o Blood Sugar: Fasting ____________ mg/dl. o Blood Sugar :Post Prandial-------------------------------- ï?? Bio-chemistry: o Blood Urea : _________________ mg/dL o Serum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relief in signs and symptoms of Fissure in AnoTimepoint: 42 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Reducing Resting Anal pressure,Reducing Anal inflammation,Healing the ulcer,Imroving Quality of Life and Improving Bowel movementTimepoint: 42 days | — |
Countries
India
Contacts
Central Ayurveda Research Institute for Drug Development