Health Condition 1: K642- Third degree hemorrhoids
Conditions
Interventions
Intervention1: Relief Piles Care (Herbal Powder): 20 g of powder once every 30 days, 3 doses every 30 days.
route of administration is oral
Sponsors
Sri Karumalaiyaan Mooligai
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male/ female participants = 18 years of age at the time of consent. 2. Participants with symptomatic internal hemorrhoids, Grades I-III by direct anoscopic visualization (anoscopic visualization not required if Grade determined by colonoscopy within 28 days prior to screening). 3. Participants who can attempt bowel movements daily. 4. Female participant of non-childbearing potential, including any female who: a) has had a hysterectomy, b) has had a bilateral oophorectomy, c) has had a bilateral tubal ligation or d) is post-menopausal (demonstration of total cessation of menses for = 1 year from the date of the screening visit) 5. Female participants of childbearing potential who agree to use two forms of contraception, one of which must be a barrier method, during the full duration of the study. 6. Participants/ Legally Acceptable Representative who are willing to provide written Informed Consent and comply with study procedures.
Exclusion criteria
Exclusion criteria: 1 Participants with Grade 4/prolapsed hemorrhoids 2 Participants having taken any herbal medications in the last 30 days 3 Participants who are planning to undergo any surgical procedure for hemorrhoids 4 Participants with major hepatic, renal, or cardiovascular ailments 5 Participants with a history of inflammatory bowel disease 6 Participants with a history of irritable bowel syndrome with constipation or diarrhea 7 Participants with clinical evidence or history of anal fissure 8 Participants with hemoglobin Greater than10.0 g/dL 9 Participants using anal, intra-anal, or intra-rectal steroids within 28 days prior to screening day 10 Pregnant and female lactating women at the time of screening 11 Participants with any condition which makes the subject unsuitable for study participation which as per the investigator would jeopardize the outcome of the trial or participant who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate and compare number of patients achieving composite score ‘0’ at the end of study (Day 30). Following symptoms will be considered for the assessment: Rectal symptoms - Tenesmus - Mucous in stools - Stool consistency - Stool frequency - bleeding per rectum - pruritus Hemorrhoidal symptoms - sphincter spasm - degree of hemorrhoids - ease of reduction.Timepoint: Day 0, Day 15, Day 30. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE)Timepoint: Day 0, Day 15, Day 30. | — |
Countries
India
Contacts
Public ContactBrindha Arumugam
iDD Research Solutions Pvt Ltd
Outcome results
None listed