| CTRI Number |
CTRI/2024/07/070363 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
31/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Siddha |
| Study Design |
Other |
|
Public Title of Study
|
Adathodai Girutham for Piles |
|
Scientific Title of Study
|
Single Centric Non-Randomized Open Clinical Trial Phase II in “Mulai Moolamâ€(Internal Haemorrhoids) with Siddha Medicine “Adathodai Girutham†among patients attending OPD at Government Siddha Medical College Hospital, Chennai. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bharath R |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College, Chennai. |
| Address |
Room No:1, Post Graduate Department of Podhu Maruthuvam, Government Siddha Medical College,Arumbakkam,Chennai.
Chennai TAMIL NADU 600106 India |
| Phone |
8525033471 |
| Fax |
|
| Email |
drbharathravi@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sasirekha R |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical College, Chennai. |
| Address |
Room No:1, Post Graduate Department of Podhu Maruthuvam, Government Siddha Medical College,Arumbakkam,Chennai.
Chennai TAMIL NADU 600106 India |
| Phone |
9444832728 |
| Fax |
|
| Email |
sasirekha.siddha@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Bharath R |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College, Chennai. |
| Address |
Room No:1, Post Graduate Department of Podhu Maruthuvam, Government Siddha Medical College,Arumbakkam,Chennai.
Chennai TAMIL NADU 600106 India |
| Phone |
8525033471 |
| Fax |
|
| Email |
drbharathravi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College, Arumbakkam, Chennai - 600106, Tamilnadu, India. |
|
|
Primary Sponsor
|
| Name |
Dr Bharath R |
| Address |
Post Graduate Department of Podhu Maruthuvam, Government Siddha Medical College,Arumbakkam,Chennai. |
| Type of Sponsor |
Other [Self] |
|
|
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 Bharath R |
Government Siddha Medical College |
Room No S1, Government Siddha Medical College, Arumbakkam, Chennai. Chennai TAMIL NADU |
8525033471
drbharathravi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,Government Siddha Medical College,Chennai. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K641||Second degree hemorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Adathodai Girutham |
This Siddha drug will be given as 4ml, BD dose for 48 days for the management of Internal Haemorrhoids. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 20 to 60 years of both gender
1 degree and 2 degree Internal Haemorrhoids
Constipation
Pruritis Ani
Bleeding per rectum
Patients willing to give specimen of blood for the
investigation |
|
| ExclusionCriteria |
| Details |
External Haemorrhoids
3 degree and 4 degree Internal Haemorrhoids
Fissure in ano
Fistula in ano
Pregnant and Lactating women
Rectal prolapse |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary Outcome will be mainly assessed by reduction in clinical symptoms and by comparing the PNR bleed scale and HSS scale before and after treatment. |
3 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary Outcome will be mainly assessed by reduction in clinical symptoms and by comparing the PNR bleed scale and HSS scale before and after treatment. |
48 Days |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
13/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 - Statistical Analysis Plan Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- 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 (Others) - NIL
- For how long will this data be available start date provided 11-06-2025 and end date provided 13-04-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The word ‘Haemorrhoids’ derived from Greek word ‘Haima’(bleed) and ‘Rhoos’(flowing) means bleeding. The word ‘Pile’ derived from Latin word ‘Pila’ means Ball. Haemorrhoids arise from the congestion of the internal and / or external venous plexus around the anal canal. They are extremely common in adults. Varicosities of the veins of the anal canal are known as haemorrhoids. It may be internal or external depending on the position of the varicosity. If it is above the Hilton’s Line it is called ’ Internal haemorrhoid’ and if it is below the Hilton’s Line it is called ’External haemorrhoid’. So internal haemorrhoid is covered by mucous membrane whereas the external haemorrhoid is covered with skin.
In India approximately 40,723,288 people are reported to have haemorrhoids. 1million new cases are reported annually, it is estimated that 50-85% 0f people around the world have haemorrhoids and in India 75% of the population is estimated. Current statistics suggest that almost half of people in their fifties have piles.
In classical siddha literature KANNUSAMI PARAMBARAI VAITHIYAM, the siddha medicine formulation ADATHODAI GIRUTHAM is indicated for the MOOLAM. It will be therapeutically effective and it also cost effective and reliable for a long duration treatment. So, the author decides to evaluate its efficacy in an open clinical trial. |