Subjects (male and females, age between 21 to 60 years) attending outpatient department of Shalya tantra and presenting with bleeding per rectum and or other symptoms of hemorrhoids will be subjected to proctoscopic examination to confirm the diagnosis of hemorrhoids, position of hemorrhoids and size of hemorrhoids (Each pile mass will be graded on a scale of 1 to 4, for size and inflammation. Grade 0 size denotes no internal haemorrhoid or flat mucosa. Grade I - small haemorrhoids, without prolapse. Grade 2 - medium size that prolapses and returns spontaneously Grade 3 - large internal haemorrhoids that prolapses but can still be manually reduced. Grade 4- very large internal haemorrhoids and cannot be manually reduced). Subjects with internal hemorrhoids (first and second degree) will be considered for recruitment. A written informed consent will be obtained from subjects for their participation in the study. Subject’s history will be recorded and his/her physical examinations will be done. Subject’s symptoms i.e. bleeding [The severity of bleeding will be assessed by number of bleeding episodes per day over a given week (Before treatment, at each follow up visit and after treatment)]. Bleeding will be considered severe if it occurs more than five times a week, moderate if it occurs three to five times per week and mild if it occurs less than three times per week. Also the quantity of bleeding at each episode of bleeding will be measured. The quantity of bleeding will be measured on 0 to 100 scale, wherein 0 indicates no bleeding and 100 indicates maximum bleeding. Symptoms such as abdominal pain/discomfort (assessment on VAS), constipation (frequency of stool per day), straining on defecation (assessment on VAS), mucus discharge, pruritis (score ranging from 0 -no symptom to 100 - itching all the time and causing severe interruption in routine activities) and pain in the anal region/perineum (assessment on VAS) will be assessed. Assessment of quality of life of subject on WHO quality of life scale will be done on screening visit. Subject will then undergo investigations i.e. fasting blood sugar, CBC, ESR, Hb%, Liver function tests, Renal function tests, Lipid profile, Urine routine and microscopic,  Stool Routine and microscopic, Urine pregnancy test (only if the subject is female of child bearing potential), HIV test (I& II), X- ray chest (PA View) and ECG.

A wash out period of 3 days will be advised during which patients will have to refrain from any medication that will have an effect on the digestive system as well as hemorrhoids (allopathic/Herbal /homeopathic etc). At baseline visit, subjects will be given 1 HDPE container of Piloset Tablet (60 Tablets) + 2 tubes of Piloset Cream. Subjects will be advised to take 2 tablets of given medicine twice daily orally after meals for 60 days. Also subjects will be advised to apply sufficient amount of given cream on pile mass twice daily for 60 days. On every follow up visit, except last visit subjects will be provided study medications. Drug compliance will be assessed by the investigator on each follow up visit and at the end of the study. Assessment of quality of life of subject on WHO quality of life scale will be done on baseline visit. 

Subjects will undergo general and systemic examinations. At baseline visit and on every follow up visit (except last follow up visit), subjects will be provided with diary card to record daily symptoms of hemorrhoids. On every follow up visit, filled diary card will be collected and symptoms will be assessed and graded on clinical symptom scoring scale.

Subjects will be called to the study center for follow up visits on every 15^th day till 60 days after the baseline visit. On every follow up visit, subjects will undergo general and systemic examinations. Assessment of clinical symptoms will also be done on every follow up visit. On every follow visit, proctoscopic examination will be done for evaluation of position and size of hemorrhoids. Assessment of pile mass will be done on every follow up visit. Also assessment of quality of life of patients on WHO quality of life scale will be done on day 30 and at the end of study i.e. on day 60.  Patient’s global evaluation for overall improvement and Investigator’s global evaluation for overall improvement will be done on completion of the study. Tolerability of the trial drugs will be assessed by the investigator and by the patient at the end of the trial. All the patients will be closely monitored for any Adverse Events starting from baseline visit till the end of the study visit. On final follow up visit (i.e. Day 60), subject’s laboratory investigations (viz. CBC, ESR, Hb%, Liver function tests, Renal function tests, Lipid profile, Stool Routine & Microscopic, Urine routine & microscopic, and ECG will be performed. After completion of 60 days of study treatment, all the subjects will be asked to stop trial medications and take advice of investigator for further treatment.