Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

The studies showed that majority of the patients were in the range (21-40) years of age. The Mean age was found to be 36.90 with SD ± 9.86. They were predominantly males. In which 80% patients were married and 33.3 % among them were having familial history. Most of them were from labour class i.e lower middle class who were using less fibrous diet, increased use of non-veg and junk food. They were having unsatisfactory bowel,constipation, passing of hard stool, straining at stool and more stay-time in toilets were completely relieved. The subjective complaints of bleeding pre-rectum, mucus discharge, pruritus ani (itching), and prolapse of pile mass were completely relived at the end of protocol with significant p-value 0.001, 0.026, 0.003 and 0.001 respectively. In the objective parameters of bleeding during examination, 80% patients were having bleeding. They showed complete relived at the end of protocol i.e 100% with significance p-value 0.001. All patients had bleeding points which were disappeared at the end of 4th follow-up with significant p-value <0.001. Out of total 83 number of primary pile masses, 32 piles masses were of grade-I and 51 pile masses were of grade-II. In grade-I primary pile mass out of 32 pile masses, 31 pile masses were relieved at the end of protocol i.e 96.88%. Overall 22 patients got completely relieved. Whereas as in grade-II pile mass group, out of 51 pile mass 38 pile mass collectively were completely disappeared i.e 74.51% (38) at the end of protocol period with p-value 0.011 moderately significant. Out of this 38 pile masses, the number of piles relieved at different positions 3, 7 and 11 O`clock were 7, 16, and 15 respectively. Overall 16 patients i.e. 31.37% were got fully cured. No report of recurrence after the end of protocol. Among all the affected patients with sphincter spasm, 94.73% were got relief. It was found that majority of patients were from Damvi mizaj followed by Balghami and Safravi mizaj. Both Damvi and Balghami mizaj patients were common sufferers. They together constituted 80% of the affected patients. No patients of saudavi mizaj come under our study.

The study is not the final and complete evaluation of the test drug but an initiation to provide base for further studies on bleeding disorders, platelet count, PPT, wound healing, collagen formation rate and muscular flaccidity or toning.