A Randomized Single Blind Parallel Group Study Comparing Monoherbal Formulation ContainingHolarrhena AntidysentericaExtract with Mesalamine in Chronic Ulcerative Colitis Patients.
BACKGROUND
Incidences of side effects and relapses are very common in chronic ulcerative colitis patients after termination of the treatment.


OBJECTIVE
This study aims to compare the treatment with monoherbal formulation ofHolarrhena antidysentericawith Mesalamine in chronic ulcerative colitis patients with special emphasis to side effects and relapse.


METHODS
Patients were enrolled from an Ayurveda Hospital and a private Hospital, Gujarat. The study was randomized, parallel group and single blind design.


METHODS
The protocol was approved by Institutional Human Research Ethics Committee of Anand Pharmacy College on 23rdJan 2013. Three groups (n = 10) were treated with drug Mesalamine (Group I), monoherbal tablet (Group II) and combination of both (Group III) respectively. Baseline characteristics, factors affecting quality of life, chronicity of disease, signs and symptoms, body weight and laboratory investigations were recorded. Side effects and complications developed, if any were recorded during and after the study.


METHODS
Results were expressed as mean ± SEM. Data was statistically evaluated usingt-test, Wilcoxon test, Mann Whitney U test, Kruskal Wallis test and ANOVA, wherever applicable, using GraphPad Prism 6.


RESULTS
All the groups responded positively to the treatments. All the patients were positive for occult blood in stool which reversed significantly after treatment along with rise in hemoglobin. Patients treated with herbal tablets alone showed maximal reduction in abdominal pain, diarrhea, and bowel frequency and stool consistency scores than Mesalamine treated patients. Treatment with herbal tablet alone and in combination with Mesalamine significantly reduced the stool infection. Patients treated with herbal drug alone and in combination did not report any side effects, relapse or complications while 50% patients treated with Mesalamine exhibited the relapse with diarrhea and flatulence after drug withdrawal.


CONCLUSIONS
Thus, monoherbal formulation alone and with Mesalamine was efficacious than Mesalamine alone in UC.
Department of Pharmacology, Anand Pharmacy College, Anand, Gujarat, India.
Sarika
S
Johari
Department of Pharmacology, Anand Pharmacy College, Anand, Gujarat, India.
Tejal
T
Gandhi
Clinical study; Holarrhena antidysenterica; mesalamine; ulcerative colitis