| CTRI Number |
CTRI/2024/04/066413 [Registered on: 26/04/2024] Trial Registered Prospectively |
| Last Modified On: |
26/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate Safety and Efficacy of herbal powder in Patients with Symptomatic Hemorrhoids |
|
Scientific Title of Study
|
A Single Center Single Arm Pilot Study Assessing Efficacy and Safety of Herbal Powder in Patients with Symptomatic Hemorrhoids |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SMM_RFP_002_23 V.1dated 31-Dec-2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Chikkalingaiah |
| Designation |
General Physician, Internal medicine |
| Affiliation |
General Physician |
| Address |
641 17 1 3 Kodigehalli
Main road Sahakar
Nagar Bengaluru
Bangalore
KARNATAKA
560092
India |
| Phone |
8248599949 |
| Fax |
|
| Email |
drchikkalingaiahmedstar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh Sharma |
| Designation |
Director Medical Affairs |
| Affiliation |
iDD Research Solutions Pvt Ltd |
| Address |
12 A First Floor 3rd Sector HSR Layout Bengaluru, Karnataka - 560102
Bangalore
KARNATAKA
560102
India |
| Phone |
8919832152 |
| Fax |
|
| Email |
yogesh@iddresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Brindha Arumugam |
| Designation |
Project Manager |
| Affiliation |
iDD Research Solutions Pvt Ltd |
| Address |
12 A First Floor 3rd Sector HSR Layout Bengaluru, Karnataka - 560102
Bangalore
KARNATAKA
560102
India |
| Phone |
9894514883 |
| Fax |
|
| Email |
brindha.arumugam@iddresearch.com |
|
|
Source of Monetary or Material Support
|
| Sri Karumalaiyaan Mooligai SKM Thottam Perumpallam Dam Kembanaickenpalayam Sathyamangangalam Erode |
|
|
Primary Sponsor
|
| Name |
Sri Karumalaiyaan Mooligai |
| Address |
Sri Karumalaiyaan Mooligai
SKM Thottam
Perumpallam Dam
Kembanaickenpalayam
Sathyamangangalam
Erode |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Chikkalingaiah |
Medstar Speciality Hospital |
641 17 1 3, Department of Internal Medicine, Kodigehalli Main road Sahakar Nagar Bengaluru
Bangalore
KARNATAKA |
8248599949
drchikkalingaiahmedstar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medstar Speciality Hospital Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K642||Third degree hemorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Relief Piles Care (Herbal Powder) |
20 g of powder once every 30 days, 3 doses every 30 days.
route of administration is oral
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
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. |
Day 0, Day 15, Day 30. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Number of Treatment Emergent Adverse Event
(TEAE) and Treatment Emergent Serious Adverse
Event (TESAE) |
Day 0, Day 15, Day 30. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
07/05/2024 |
| Date of Study Completion (India) |
15/07/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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 - NO
|
|
Brief Summary
|
Hemorrhoids may develop for a number of reasons, such as constipation, obesity, a diet low in fiber, prolonged sitting or standing, deteriorating muscle tone with age, colon cancer, or consequences from surgery or trauma. Bleeding from the lower gastrointestinal segments is most likely to be the main prevalent etiological reason of the incidence of hemorrhoids. Anal pain and discomfort, itching, bleeding, swelling, and perceived mass in the perianal zone are considered as the main symptoms of hemorrhoids. If left untreated, hemorrhoids can worsen and become complicated over time. Conservative methods of treatment for haemorrhoids are covered, including oral rehydration, non steroidal anti-inflammatory medications, rest, and dietary fibre, as well as surgical treatments with varying degrees of complications. Surgical hemorrhoidectomy should be reserved for patients with grade IV hemorrhoids and some patients with grade III hemorrhoids who have not responded to office procedures or cannot tolerate them. There are many complications following office-based procedures and operations such as stenosis, infection, fibrosis, fecal incontinence, urinary retention, and ectropion.
|