Venue of the study: Dept., of Gastroenterology, Malar Hospitals, Gandhinagar, Chennai, India.

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1 Clinical Study No. 1 Clinical evaluation of VeinCare capsules in the management of hemorrhoids Double blind placebo controlled study (Ganesh et al. Sent for publication ) Venue of the study: Dept., of Gastroenterology, Malar Hospitals, Gandhinagar, Chennai, India. Objectives of the study: To evaluate the clinical safety and efficacy of VeinCare in the management of hemorrhoids (piles). Study design: Double blind placebo controlled clinical evaluation Primary end points: Clinical recovery from symptoms of Hemorrhoids: - Anal discomfort - Rectal bleeding - Pain during defecation Secondary end points: - Safety profile of VeinCare capsules - Patients acceptability of VeinCare Inclusion criteria - Adult patients of both sexes aged between 18 and 65 years - Clinical diagnosis of grade I and grade II hemorrhoids - Evidence of rectal bleeding, itching, anal discomfort and pain during defecation. - Colonoscopic evidence of internal piles Exclusion criteria - Evidence of malignancy - Pregnancy - Lactation - History of allergy to medications - Children

2 Composition Each VeinCare capsule contains: Name of the plant Qty. (mg) Exts. Commiphora mukul 65 Shilajeet 8 Azadirachta indica 4 Berberis aristata 64 Emblica officinalis 32 Terminalia chebula 32 Terminalia belerica 32 Cassia fistula 32 Bauhinia variegata 32 Mesua ferrea 6 Methodology Fifty patients of hemorrhoids attending the out patient wing of Gastroenterology Department of Malar Hospitals, Chennai, India, were selected for the study. Patients of protrusion of mass, anal plexus, bleeding per anus, pain, and itching were selected included in the study after clinical and physical examination. Patients who had grade I and grade II hemorrhoids were selected for the study. First grade hemorrhoids were defined as hypertrophy and hypertrophy of internal hemorrhoidal plexus which remain entirely within the anal canal. Second degree hemorrhoid is defined as descend and prolapse of hemorrhoids during defecation but spontaneous reduction at the end of defecation. These patients were randomly divided into 2 groups and received VeinCare or placebo capsule in a dose of 1 capsule twice a day for 1 month. All the patients underwent colonoscopy to confirm hemorrhoids and rule out other diseases. The patients attended the out patient dept., every for 4 s. During these visits, signs and symptoms of hemorrhoids like rectal bleeding, itching, anal discomfort, pain and discharge of mucus were evaluated and scored as 0 = none, 1 = mild, 2 = moderate and 3 = severe. At the end of the study, the evaluation of overall impression by the patients and the investigator were recorded as 4 = Totally symptom free (100% relief from symptoms) 3 = Marked improvement in symptoms (75 to 99% relief from symptoms) 2 = Moderate improvement (50 to 74% relief from symptoms) 1 = Slight improvement (Less than 50 % relief from symptoms) 0 = No improvement (-) 1= Symptoms became worse Adverse effects if any were recorded during the ly visits of the patients. Protocol of the study was approved by the hospitals ethics committee Statistical analysis The results were analysed statistically using repeated measures of ANOVA and Friedmen test. In addition, Dunnett s Multiple Comparison Posthoc test was also applied.

3 Results All the 50 patients completed the study period without any interruption. The entry characteristics are tabulated in table no. 1. There were no significant differences between VeinCare and placebo group as far as entry characteristics are concerned. Patients on VeinCare showed significant improvement in their symptoms from 1 st onwards till the end of the study (Table 2). Table 1: Entry characteristics Parameter VeinCare (n=25) Placebo (n=25) Age ( years ) ± 5.8 Mean weight (kg) 58.5 ± ± 9.5 Sex ratio (M:F) 11:14 12:13 Mean rectal bleeding score Itching ±1 0.4 Anal discomfort Pain ± 0.6 Discharge of mucus Table 2: Effect of drug therapy on symptoms of hemorrhoids Parameter VeinCare (n=25) Placebo (n=25) At entry 1 st 2 nd 3 rd 4 th At entry 1 st 2 nd 3 rd Mean rectal 1 0* ± 0.17* ± 0.02* ± 0.9 bleeding Itching Anal discomfort Pain Discharge 1.2 of mucus *p< ± * * ± 0.18* * ± 0.05* ± ± th ±

4 Over all response to treatment at 4 th is mentioned in Table No. 3. Table 3: Overall response to treatment at 4 th VeinCare (n=25) Placebo (n=25) Response patient investigator patient investigator Totally symptoms free 20/25 20/25 2/25 2/25 Marked improvement 3/25 4/25 0/25 0/25 No improvement 2/25 1/25 23/25 23/25 The results indicate that VeinCare significantly decreased most of the symptoms of hemorrhoids from 1 st onwards and the trend continued till the end of the study, whereas patients on placebo did not respond significantly. Rectal bleeding significantly decreased in patients on VeinCare, similarly pain during defecation, discharge of mucus and itching also significantly decreased in VeinCare group. Overall response treatment at the end of the study also indicate that VeinCare brought about statistically significant improvement in the symptomatology of hemorrhoids and this was evident by the overall response to the treatment as indicated by the patients and the investigator. Overall response to treatment was assessed by interviewing the patients at the end of study period. In VeinCare group 20 out of 25 patients were symptom free and all these patients felt that they had excellent response to other symptoms. Adverse effects VeinCare was well tolerated by all the patients throughout the treatment period without any evidence of adverse effects. Drop outs Nil Discussion Hemorrhoids are dilated veins occurring in relation to the anus. Such hemorrhoids may be external or internal, i.e., external or internal to the anal orifice. The internal hemorrhoids are classified according to their degree of prolapse into first degree where hemorrhoidal plexus remain entirely within the anal canal. The second degree hemorrhoids will descend and prolapse during defecation followed by spontaneous reduction. There is no specific therapy available to manage these hemorrhoids. VeinCare a polyherbal formulation has been claimed to have beneficial effects in the management of hemorrhoids. The present study indicates efficacy and safety of VeinCare in the management of hemorrhoids. The main ingredients of VeinCare are Commiphora mukul, Shilajee, Azadirachta indica, Berberis aristata, Embelia officinalis, Terminlaia chebula, Terminalia belerica, Cassia fistula, Bauhinia variegata, and Mesua ferrea. Commiphora mukul has active principles like Guggulusterones Z&E, Guggulusterols I-IV, a terpene hydrocarbon etc. The guggulusterone fraction of gum Guggul exhibited anti-inflammatory activity in the models of acute inflammation, which was comparable to approximately one-fifth that of hydrocortisone and equal to phenylbutazone and ibuprofen (Khare, 2007a). The leaf & bark of Azadirachta indica has antimicrobial,

5 antifungal, anthelmintic, insecticidal, antiviral, antipyretic, anti-inflammatory activities. The same is used in inflammatory gum diseases, boils, sores, measles, small pox, and other cutaneous affections (Khare, 2007b). In another study reported that Cassia could be safely utilized as laxative drugs (Akanmu et al., 2004). The fruit of Terminlia belerica is laxative when half ripe (Khare, 2007c). The extract of Berberis aristata has laxative, and antiseptic activites. And reports also suggest that the same is prescribed externally for conjunctivitis, ulcers, and sores (Khae, 2007d).. Emblica officinalis has antiviral, antibacterial and antiallergy activities that are helpful in managing the clinical symptoms of hemorrhoids (Rathish Nair and Sumitra Chandra, 2007). In ethnomedicinal approaches extract of Bauhinia variegata is used due to its varied pharmacological activities like wound-healing promoter, laxative and astringent activities (Ravindra et al., 2007). Mesua ferrea is known for its therapeutic application in managing the bleeding piles (Khare, 2007e). Conclusion VeinCare has beneficial effects in patients of hemorrhoids. It brings about symptomatic relief without any adverse effects. It has been well accepted by the patients because of its efficacy and safety. References: Akanmu, M.A., Iwalewa,E.O., Elujoba, A.A., Adelusola, K.A. Toxicity Potentials of Cassia Fistula Fruits as Laxative with Reference to Senna. African Journal of Biomedical Research, Vol. 7 (2004); Khare CP. (2007b). Indian Medicine: An illustrated dictionary. Springer. New Delhi. p. 75. Khare CP. (2007a). Encylopedia of Indian Medicine. Springer. Germany. pp Khare CP. (2007c). Indian Medicine: An illustrated dictionary. Springer. New Delhi. pp Khare CP. (2007d). Indian Medicine: An illustrated dictionary. Springer. New Delhi. pp Khare CP. (2007e). Indian Medicine: An illustrated dictionary. Springer. New Delhi. pp Rathish Nair, Sumitra V. Chanda. (2007). Antibacterial Activities of Some Medicinal Plants of the Western Region of India. Turk J. Biol. 31: Ravindra G.Mali, Shailaja G.Mahajan, Anita A.Mehta. (2007). Rakta Kanchan (Bauhinia variegata): Chemistry, Traditional and Medicinal uses- a review. Pharmacognosy Reviews. Vol 1, Issue 2, Jul-Dec.