| CTRI Number |
CTRI/2024/05/068124 [Registered on: 30/05/2024] Trial Registered Prospectively |
| Last Modified On: |
25/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
Brahmi Nei for Diabetic Neuropathy |
|
Scientific Title of Study
|
Single Centric Non- Randomized Open Clinical Trial Phase II in Karathambam among Madhumegam patients ( Diabetic Neuropathy ) with siddha medicine Brahmi nei
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 |
S Shalini |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College Arumbakkam, Chennai. |
| Address |
Room No S1 Government Siddha Medical College Arumbakkam
Chennai 106
Tamilnadu
Chennai
TAMIL NADU
600106
India |
| Phone |
8903422672 |
| Fax |
|
| Email |
kalamshalini2020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R MENAKA |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical College Arumbakkam, Chennai. |
| Address |
Room no S1 Government Siddha Medical College Arumbakkam
Chennai 106
Tamilnadu
Chennai
TAMIL NADU
600106
India |
| Phone |
9444669661 |
| Fax |
|
| Email |
rangasamymenaka75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shalini S |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College Arumbakkam, Chennai. |
| Address |
Room no S1 Government Siddha Medical College Arumbakkam
Chennai 106
Tamilnadu
Chennai
TAMIL NADU
600106
India |
| Phone |
8903422672 |
| Fax |
|
| Email |
kalamshalini2020@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College,Arumbakkam,Chennai-600106 |
|
|
Primary Sponsor
|
| Name |
SHALINI S |
| Address |
Room no S1,Government Siddha Medical College, Arumbakkam,
Chennai
TAMIL NADU
600106
India |
| 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 |
| SHALINI S |
Government Siddha Medical College, Arumbakkam, Chennai. |
Room no
S1,Department of PG
Pothu Maruthuvam,Gov
ernment Siddha
Medical College,
Arumbakkam, Chennai
Chennai
TAMIL NADU
Chennai
TAMIL NADU |
8903422672
kalamshalini2020@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, GSMC, Chennai -106 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G629||Polyneuropathy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brahmi Nei for Diabetic Neuropathy |
2 parts of Fresh juice of Brahmi plant will be obtained.
The fresh juice of Brahmi plant will be mixed with the 1 part of Cow’s ghee
Then the mixture will be allowed to boil till it reaches the ghee consistency.
Dosage : 5 g bd
Duration : 48 days
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
K/C/O of Type 2 Diabetes Mellitus more than 5 years
Stage N2a and N2b (NCBI staging of Diabetic Neuropathy)
|
|
| ExclusionCriteria |
| Details |
Alcohol-associated neuropathy
Nutritional linked neuropathy
Uremic neuropathy
Vulnerable people
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Outcome will be assessed by:
Measuring the reduction in severity of signs and symptoms using staging scales, such as transitioning from,
N2b to N2a/N1a/ NO
N2a to N1a/NO
N1a to NO
|
48 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Measuring the reduction in severity of signs & symptoms
|
40 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)
|
09/09/2024 |
| 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 04-06-2025 and end date provided 15-08-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Peripheral neuropathies are diseases of the peripheral nervous system that can be divided into mononeuropathies, multifocal neuropathies, and polyneuropathies. The first symptoms tend to be sensory and consists of tingling, prickling, burning or bandlike dysesthesias in the balls of the feet or tip of the toes or in a general distribution over the soles.The tingling sensation started distally and limited in the “Glove and stocking†distribution.Peripheral Neuropathy may be due to various cause Hereditary, Metabolic causes, Nutritional Deficiency, Connective tissue disorders, Infection, Toxins and Malignancy. Diabetic Neuropathy is the most common cause of Peripheral neuropathy and it ranges from 54% among 1,00,000 people per year. In epidemiological studies from India showed wide prevalence varying from 5 to 2400 per 10,000 population in different community studies.6 Peripheral Neuropathies progress slowly, over more than 5 years. Different clinical neurological scales can be used to assess the severity of Diabetic polyneuropathy. On the basis of NCBI Staging, NO— No neuropathy N1a— Signs but no symptoms of neuropathy N2a— Symptomatic mild diabetic polyneuropathy N2b— Severe symptomatic diabetic polyneuropathy (as in N2a but patient unable to heel walk) N3— Disabling diabetic polyneuropathy
|