| CTRI Number |
CTRI/2018/03/012713 [Registered on: 21/03/2018] Trial Registered Prospectively |
| Last Modified On: |
23/02/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to study the effect of drug NELLI KUDINEER in RATHAMOOLAM(Bleeding Haemorrhoids) |
|
Scientific Title of Study
|
A Prospective Open Labelled Phase II Non Randomized clinical study of NELLI
KUDINEER for RATHAMOOLAM(Bleeding Haemorrhoids) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sumayya M |
| Designation |
PG student |
| Affiliation |
Govt Siddha Medical College and hospital Palayamkottai |
| Address |
PG second year Department of Pothumaruthuvam Govt Siddha Medical College and hospital Palayamkottai Tirunelveli Tamilnadu
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9746242799 |
| Fax |
|
| Email |
sumisuhyle@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr A Manoharan MD |
| Designation |
Head of Department Department of Pothumaruthuvam |
| Affiliation |
Govt Siddha Medical College and hospital Palayamkottai |
| Address |
Head of Department Department of Pothumaruthuvam Govt Siddha Medical College Palayamkottai Tirunelveli Tamilnadu
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443886700 |
| Fax |
|
| Email |
drmanoharan25@Gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr A Manoharan MD |
| Designation |
Head of Department Department of Pothumaruthuvam |
| Affiliation |
Govt Siddha Medical College and hospital Palayamkottai |
| Address |
Head of Department Department of Pothumaruthuvam Govt Siddha Medical College Palayamkottai Tirunelveli Tamilnadu
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443886700 |
| Fax |
|
| Email |
drmanoharan25@Gmail.com |
|
|
Source of Monetary or Material Support
|
| Library Government Siddha Medical college and hospital
Palayamkottai |
| OPD and IPD
Govt Siddha Medical College and hospital
Palayamkottai |
|
|
Primary Sponsor
|
| Name |
Dr S Neelavathi Md PhD |
| Address |
Principal Govt Siddha Medical College and hospital Palayamkottai Tirunelveli Tamilnadu |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Sumayya M |
Govt Siddha Medical College and hospital |
Opd
Room Number 10
PG Department of Pothu Maruthuvam Government Siddha Medical college and hospital
Palayamkottai
Tirunelveli
TAMIL NADU |
9746242799
sumisuhyle@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
RATHAMOOLAM, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NELLI KUDINEER |
100ml Orally OD Before food for 30 days |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient with haemorrhoids in grade I II III with clinical symptoms such as Bleeding per rectum Irregular bowel habits Constipation Prolapse of pile mass Itching around anus Tenesmus and Anemia |
|
| ExclusionCriteria |
| Details |
Fissure Fistula in ano Prolapse of rectum Sentinel haemorrhoids Malignancy Rectal polyp Pregnant women Chronic Kidney,Liver and cardiac diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Therapeutic efficacy of trial drug Nelli kudineer in Rathamoolam |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of Siddha diagnostic parameters Safety of trial drug Pharmacological and Biochemical analysis of trial drug |
30 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)
|
03/04/2018 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is A Prospective Open Labelled Phase II Non Randomized clinical study to evaluate the therapeutic efficacy of NELLI KUDINEER 100ml OD for 30 days in 40 patients during the trial period of 15 months that will be conducted in Govt Siddha Medical College and hospital Palayamkottai Tirunelveli Tamilnadu The primary outcome will be the therapeutic efficacy of trial drug NELLI KUDINEER in RATHAMOOLAM The secondary outcome will be the evaluation of Siddha diagnostic parameters Safety of trial drug Pharmacological and Biochemical analysis of trial drug |