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Clinical evaluation of Ayurvedic formulation in the Management of parikartika(Fissure in Ano)

Clinical evaluation of Ayurvedic formulation in the Management of Parikartika(Fissure in Ano) - Parikartika(FIA)

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/06/008773
Enrollment
60
Registered
2017-06-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patient of Anal fissure

Interventions

Intervention1: Drug Intervention-Jatyadi Ghrita and Jatyadi Taila Local application: Group I 1. Jatyadi Ghrita (Ref: Ashtangahridaya, A.F.I.- I, API Part II, Vol.I) Dose: Q.S. Dosage form: Ghrita

Sponsors

CCRASNew Delhi
Lead Sponsor

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

MeasureTime frame
Relief in signs and symptoms of Fissure in AnoTimepoint: 42 days

Secondary

MeasureTime frame
Reducing Resting Anal pressure,Reducing Anal inflammation,Healing the ulcer,Imroving Quality of Life and Improving Bowel movementTimepoint: 42 days

Countries

India

Contacts

Public ContactDr Laxmidhar Barik

Central Ayurveda Research Institute for Drug Development

ldbarik1963@yahoo.co.in9433110117

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026