| CTRI Number |
CTRI/2025/05/086594 [Registered on: 08/05/2025] Trial Registered Prospectively |
| Last Modified On: |
06/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Trial on Nelliyathy Kashayam in the Management of Madhumegam (Diabetes Mellitus) |
|
Scientific Title of Study
|
A Prospective Open Labelled, Single Arm, Non- Randomized, Single Centric, Phase II Clinical Trail To Determine The Effectiveness Of Nelliyathy Kashayam In The Management Of Madhumega Noi (Diabetes Mellitus)
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrRNoorul Hasina |
| Designation |
PG scholar |
| Affiliation |
Government Siddha Medical College and hospital, Palayamkottai |
| Address |
Department of Pothu Maruthuvam,Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli-627002
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9566648034 |
| Fax |
|
| Email |
hasinarasheed26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T Komallavalli MDs PhD |
| Designation |
Head of the Department |
| Affiliation |
Government Siddha Medical College, Palayamkottai |
| Address |
Department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli-627002
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9788122691 |
| Fax |
|
| Email |
komalaarumugam1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T Komallavalli MDs PhD |
| Designation |
Head of the Department |
| Affiliation |
Government Siddha Medical College, Palayamkottai |
| Address |
Department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli-627002
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9788122691 |
| Fax |
|
| Email |
komalaarumugam1@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD facilities and Central Library of Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli-627002 |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College and Hospital |
| Address |
Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli, Tamilnadu,India.
Pincode - 627002 |
| 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 |
| Dr R Noorul Hasina |
Government Siddha Medical College and Hospital |
PG Department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli-627002, Tamilnadu
Tirunelveli
TAMIL NADU |
9566648034
hasinarasheed26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE, GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL, PALAYAMKOTTAI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nelliyathy Kashayam |
½ Aalaaku (84ml),Twice a day
Duration : 90 days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Even if patient is having any one among the three (WHO criteria 2019):
FBS - above126 mg/dl and below 250mg/dl or
PPBS - above 200mg/dl and below 350mg /dl or
HbA1c 6.5 to 10
Patients with symptoms of polyuria, polydipsia, polyphagia,asthenia,nocturia,obesity (metabolic syndrome),numbness, tingling sensation.
|
|
| ExclusionCriteria |
| Details |
Type 1 diabetes mellitus
Gestational DM
Diabetes insipidus
Pregnancy
Lactating mother
Chronic kidney disease
Chronic lever disease
Ischemic heart diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| If during treatment or after treatment FBS became below 126 mg dl & PPBS below 200 mg dl and HbA1c below 6.5 |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction of the sign and symptoms of polyuria, polydipsia, polyphagia, asthenia, nocturia, numbness, tingling sensation, nausea, mood changes and irritability, difficulty in concentration |
90 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)
|
25/05/2025 |
| 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
|
This study is a Prospective Open Labelled, Single arm, Non-Randomized, Single centric, Phase II Clinical trial to determine the Effectiveness of NELLIYATHY KASHAYAM in the management of MADHUMEGA NOI (DIABETES MELLITUS). The trial drug will be administered at the dose of 1-2 gram twice a day 90 days in 40 patients. The trial period of 12 months will be carried out in Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli 627002 , Tamil nadu. The primary outcome will be the evaluation of therapeutic efficacy of the trial drug NELLIYATHY KASHAYAM. The secondary outcome will be the evaluation of Siddha diagnostic parameters, Assessment of pharmacological and biochemical parameters of the trial drug. In case of any adverse events(AE) is noticed and it will be referred to pharmacovigilance department of SCRI. Further management of patients Will be given in OPD facility. |