Treatment of Piles by Ayurvedic Sunarin Capsules

Evaluation of the Efficacy and Safety of Sunarin Capsules in patients with Grade 2 Internal Hemorrhoids - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/092487

Enrollment

Registered

2025-08-06

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K641- Second degree hemorrhoids

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Patients Diagnosed with Grade 2 haemorrhoids clinically and by proctoscopy confirmation Patients willing to provide written informed consent Patients Presenting with at least two of the following symptoms bleeding per rectum pain during defecation prolapse or altered bowel habits Patients able and willing to comply with study protocol and follow up

Exclusion criteria

Exclusion criteria: Patients with Grade 4 hemorrhoids and prolapse hemorrhoids Patients with Associated anal conditions like Anal Fissure Fistula in ano Abscess Patients with systemic illnesses like Diabetes Mellitus Tuberculosis Malignancy Liver or Renal dysfunction Patients with known bleeding disorders or on anticoagulant therapy Immunocompromised patients like HIV HBsAg HCV positive Pregnant or lactating women Prior surgical treatment for hemorrhoids Patients currently on other Allopathic or Ayurvedic hemorrhoid medications Patients Unwillingness to participate or non compliance with treatment follow up

Design outcomes

Primary

Measure	Time frame
Evaluation of efficacy and safety of Sunarin Capsules in Patients with Grade 2 HaemorrhoidsTimepoint: Evaluation of efficacy and safety of Sunarin Capsules in Patients with Grade 2 Haemorrhoids on 7 14 21 28 42 and 56 Day	—

Secondary

Measure	Time frame
To evaluate the therapeutic efficacy of capsule sunarin in the management of symptoms and severity of haemorrhoids as measured by PNR Bleed score Hemorrhoidal Severity Score Victoria Bowel Performance Scale Visual Analogue Scale for Pain Quality of Life by Haemorrhoidal Disease Severity Score questionnaire Timepoint: To evaluate the therapeutic efficacy of capsule sunarin in the management of symptoms and severity of haemorrhoids as measured by PNR Bleed score Hemorrhoidal Severity Score Victoria Bowel Performance Scale Visual Analogue Scale for Pain Quality of Life by Haemorrhoidal Disease Severity Score questionnaire on 0 7 14 21 28 42 and 56 Day;To assess the Safety and tolerability of Sunarin capsules by Monitoring and documentation of adverse events or serious adverse events Patient reported tolerance and compliance and Requirement of any rescue medications Timepoint: To assess the Safety and tolerability of Sunarin capsules by Monitoring and documentation of adverse events or serious adverse events Patient reported tolerance and compliance and Requirement of any rescue medications from 0 to 56 day;To monitor Recurrence or persistence of symptoms such as Per Rectal bleeding prolapse pain or discomfort after the duration of treatment Timepoint: To monitor Recurrence or persistence of symptoms such as Per Rectal bleeding prolapse pain or discomfort after the duration of treatment on 42 and 56 Day;To address the Relevance of Study drug usage in conditions such as Advanced stages of Haemorrhoids and in cases of Post Operative Haemorrhoidectomy Timepoint: NIL	—

Measure

Time frame

To evaluate the therapeutic efficacy of capsule sunarin in the management of symptoms and severity of haemorrhoids as measured by PNR Bleed score Hemorrhoidal Severity Score Victoria Bowel Performance Scale Visual Analogue Scale for Pain Quality of Life by Haemorrhoidal Disease Severity Score questionnaire Timepoint: To evaluate the therapeutic efficacy of capsule sunarin in the management of symptoms and severity of haemorrhoids as measured by PNR Bleed score Hemorrhoidal Severity Score Victoria Bowel Performance Scale Visual Analogue Scale for Pain Quality of Life by Haemorrhoidal Disease Severity Score questionnaire on 0 7 14 21 28 42 and 56 Day;To assess the Safety and tolerability of Sunarin capsules by Monitoring and documentation of adverse events or serious adverse events Patient reported tolerance and compliance and Requirement of any rescue medications Timepoint: To assess the Safety and tolerability of Sunarin capsules by Monitoring and documentation of adverse events or serious adverse events Patient reported tolerance and compliance and Requirement of any rescue medications from 0 to 56 day;To monitor Recurrence or persistence of symptoms such as Per Rectal bleeding prolapse pain or discomfort after the duration of treatment Timepoint: To monitor Recurrence or persistence of symptoms such as Per Rectal bleeding prolapse pain or discomfort after the duration of treatment on 42 and 56 Day;To address the Relevance of Study drug usage in conditions such as Advanced stages of Haemorrhoids and in cases of Post Operative Haemorrhoidectomy Timepoint: NIL

—

Countries

India

Contacts

Public ContactDr Amarprakash Dwivedi

D Y Patil Deemed to be University School of Ayurveda

amar.dwivedi@dypatil.edu9022325666

Outcome results