CTRI

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CTRI Number

CTRI/2025/08/092487 [Registered on: 06/08/2025] Trial Registered Prospectively

Last Modified On:

05/08/2025

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Single Arm Study

Public Title of Study

Treatment of Piles by Ayurvedic Sunarin Capsules

Scientific Title of Study

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

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Amarprakash Dwivedi
Designation	Professor
Affiliation	D Y Patil Deemed to be University School of Ayurveda
Address	Department of Shalyatantra D Y Patil Deemed to be University School of Ayurveda Sector 7 Nerul Navi Mumbai Thane MAHARASHTRA 400706 India
Phone	9022325666
Fax
Email	amar.dwivedi@dypatil.edu

Details of Contact Person
Scientific Query

Name	Dr Amarprakash Dwivedi
Designation	Professor
Affiliation	D Y Patil Deemed to be University School of Ayurveda
Address	Department of Shalyatantra D Y Patil Deemed to be University School of Ayurveda Sector 7 Nerul Navi Mumbai MAHARASHTRA 400706 India
Phone	9022325666
Fax
Email	amar.dwivedi@dypatil.edu

Details of Contact Person
Public Query

Name	Dr Amarprakash Dwivedi
Designation	Professor
Affiliation	D Y Patil Deemed to be University School of Ayurveda
Address	Department of Shalyatantra D Y Patil Deemed to be University School of Ayurveda Sector 7 Nerul Navi Mumbai MAHARASHTRA 400706 India
Phone	9022325666
Fax
Email	amar.dwivedi@dypatil.edu

Source of Monetary or Material Support

D Y Patil Ayurvedic Hospital Nerul Navi Mumbai

Primary Sponsor

Name	S G Phytopharma Private Limited
Address	S G Phytopharma Private Limited 532 1 Nilgiri Apartments Plot No 3 Rajendranagar Ring Road Kolhapur Maharashtra India 416004
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor

Name	Address
NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Amarprakash Dwivedi	D Y Patil Ayurvedic Hospital	Shalyatantra OPD 3 First Floor D Y Patil Ayurvedic Hospital Sector 7 Nerul Navi Mumbai Thane MAHARASHTRA	9022325666 amar.dwivedi@dypatil.edu

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee of D Y Patil Deemed to be University School of Ayurveda	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:K641\|\|Second degree hemorrhoids. Ayurveda Condition: ARSAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Other than Classical		(1) Medicine Name: Sunarin Capsule, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 600(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Lukewarm Water), Additional Information: An Ayurvedic Proprietary Medicine

Inclusion Criteria

Age From	20.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	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

ExclusionCriteria

Details

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

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Evaluation of efficacy and safety of Sunarin Capsules in Patients with Grade 2 Haemorrhoids	Evaluation of efficacy and safety of Sunarin Capsules in Patients with Grade 2 Haemorrhoids on 7 14 21 28 42 and 56 Day

Secondary Outcome

Outcome	TimePoints
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	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	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	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	NIL

Target Sample Size

Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50"

Phase of Trial

Phase 3/ Phase 4

Date of First Enrollment (India)

18/08/2025

Date of Study Completion (India)

04/12/2025

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="0"
Months="4"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Completed

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

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

Response - YES

What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identiﬁcation (text, tables, ﬁgures, and appendices).

What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identiﬁed for this purpose.

For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.

By what mechanism will data be made available?
Response - Proposals should be directed to [info@sgphyto.com].

For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2031?
Response - Immediately following publication. No end date.

Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL

Brief Summary

Sunarin capsules is a proprietary Ayurvedic formulation developed by SG Phyto Pharma Pvt Ltd are indicated in the management of haemorrhoids. The formulation contains a blend of classical herbs known for their anti-inflammatory hemostatic analgesic and wound healing properties including Berberis aristata Mimosa pudica Mesua ferrea Emblica officinalis and others. These herbs have been traditionally used in treating bleeding disorders anorectal diseases and digestive disturbances. Sunarin is formulated to act locally on hemorrhoidal tissue and systemically to restore gastrointestinal balance reduce congestion and promote mucosal healing.

Given the pharmacological properties of the ingredients and their synergy it is hypothesized that Sunarin capsules will offer symptomatic relief in Grade 2 haemorrhoids with good tolerability and minimal side effects. The proposed study aims to evaluate the efficacy and safety of Sunarin capsules in an Open label Single arm Interventional Prospective Clinical Study. By utilizing validated objective parameters such as PNR Bleed Classification Hemorrhoidal Severity Score VAS for pain and Victoria Bowel Performance Scale the study will generate scientific evidence for its therapeutic potential and assess its impact on recurrence over a 56 day period.