| CTRI Number |
CTRI/2023/12/060626 [Registered on: 21/12/2023] Trial Registered Prospectively |
| Last Modified On: |
20/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
A study on internal haemorrhoids using siddha medicine Moolanoi chooranam |
|
Scientific Title of Study
|
Phase II non randomized open clinical evaluation of siddha medicine moolanoi chooranam
for the management of ull moolam (internal haemorrhoids) |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aarthi G |
| Designation |
PG scholar |
| Affiliation |
Government siddha medical college chennai |
| Address |
Post Graduate Department of pothu maruthuvam, Government siddha medical college arumbakkam,chennai 106.
Chennai
TAMIL NADU
600106
India |
| Phone |
9944325128 |
| Fax |
|
| Email |
rthig30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRNANBU |
| Designation |
Head of the department |
| Affiliation |
Government siddha medical college chennai |
| Address |
Post Graduate Department of pothu maruthuvam, Government siddha medical college arumbakkam,chennai 106.
Chennai
TAMIL NADU
600106
India |
| Phone |
9443279412 |
| Fax |
|
| Email |
nanbu.sumi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aarthi G |
| Designation |
PG scholar |
| Affiliation |
Govt siddha medical college chennai |
| Address |
Post Graduate Department of pothu maruthuvam, Government siddha medical college arumbakkam,chennai 106.
Chennai
TAMIL NADU
600106
India |
| Phone |
9944325128 |
| Fax |
|
| Email |
rthig30@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government siddha medical College arumbakkam chennai 106 |
|
|
Primary Sponsor
|
| Name |
Aarthi G |
| Address |
Post Graduate Department of pothu maruthuvam, Government siddha medical College arumbakkam chennai 106 |
| 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 Aarthi G |
Government Siddha Medical College, Chennai |
Room NO.S1, Department of PG Pothu Maruthuvam,Government siddha medical college Arumbakkam, Chennai 106.
Chennai
TAMIL NADU |
9944325128
rthig30@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Government Siddha Medical College,Chennai. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K629||Disease of anus and rectum, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Moolanoi chooranam |
The siddha drug will be given as 2 grams BD dose with honey 48 days for the management of internal haemorrhoids. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with symptoms like constipation, bleeding during defecation, Pain in the anal region. Grade 1 degree haemorrhoids. |
|
| ExclusionCriteria |
| Details |
Second, third and fourth degree haemorrhoids, fissures in ano, fistula,CA rectum, rectal prolapse, pregnant and lactating mothers, Diabetes mellitus, Hypertension. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome is assessed by reduction in clinical symptoms measured by haemorrhoids severity score scale. |
Primary outcome is assessed within 3 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Discharge cessation in bleeding during defecation. |
Secondary outcome is assessed within 7 weeks. |
|
|
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)
|
31/12/2023 |
| 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="1"
Months="0"
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 - NO
|
|
Brief Summary
|
Varicosities of the veins of the anal canal are known as haemorrhoids. Haemorrhoids may arise from internal or external around the anal canal. There are four degree where as first degree remain in rectum. Second degree prolapse through anus on defecation and spontaneously reduce but third degree requires digital reduction and fourth remains persistently prolapsed. Approximately 50 to 66% of people have haemorrhoids at some point in their lives. The aim of the study is the management of ull moolam (internal haemorrhoids ) with siddha medicine moolanoi chooranam and the objective is to determine the therapeutic efficacy and safety profile of siddha medicine moolanoi chooranam in the management of ull moolam. As the literary evidence, hypothesis is created such a way for the efficacy of Moolanoi chooranam will be a better solution for ull moolam (internal haemorrhoids). |