Health Condition 1: K929- Disease of digestive system, unspecified
Conditions
Interventions
None listed
Sponsors
CCRAS
Eligibility
Inclusion criteria
Inclusion criteria: Subjects of either sex with age between 18 and 60 years Subjects diagnosed of parikarthika with pain, bleeding per rectum and constipation. Subjects, willing to give written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: Subjects who are also suffering from, hemorrhoids, fistula in ano, peri anal abscess, fecal incontinence, and anal stenosis Acute fissure in ano, Secondary fissures, fissures located at lateral location and multiple fissures 3. Subjects with co-morbidity such as Diabetes Meletus, uncontrolled Hypertension, inflammatory bowel disease, Sexually transmitted diseases, Hepatitis B and C, tuberculous ulcer, clinically significant renal disease, hepatic disease, cardiovascular disease and psychological diseases Subjects on active drug abuse, alcoholics and on medication hampering wound healing. Known sensitivity to any of the trial drugs or their ingredients Subjects who are already underwent operative treatment and under non operative treatments like botulinum inj or calcium channel blockers or topical nitrates. Subjects who are currently undergoing either of the trial intervention within 30 days of randomization of the study. Pregnant/lactating woman. Any other condition which the Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •Assessment of reduction in rate of recurrence of parikarthika i e the percentage of participant reported symptoms of fissure validated by physical examination, after the management with ayurveda protocol in comparison with diltiazem topical application. Timepoint: 8th week 12th week and 112th week | — |
Secondary
| Measure | Time frame |
|---|---|
| • Assessment of treatment efficacy of management protocol evaluated using the REALISE score, by degree of healing (Re epithelialization) scoring system and by spasm of anal sphincters in comparison with diltiazem topical application • Assessment of the safety of the Ayurveda management protocol regimen through reported incidence of adverse events ((Time frame: 14th day,28th day,56th day,84th day,112thday) and also laboratory safety parameters from baseline (CBC, LFT, KFT) • Assessment of comparative tolerability of the management protocol and diltiazem topical application through reported incidence of adverse events during the study period • Change in health-related quality of life from baseline assessed through SF-12 questionnaire and patient satisfaction rated on a scale of 0 (failure) to 5 (excellent). Timepoint: efficacy (Time frame: 14th day,28th day,56th day,84th day,112th day) safety (Time frame: baseline, and 84th day) tolerability (Time frame: 14th day and 28thday) quality of life (Time frame: 14th day,28th day,56th day,84th day,112th day) | — |
Countries
India
Contacts
Public ContactDr Indu P P
National ayurveda research institute for panchakarma Cheruthuruthy
Outcome results
None listed