| CTRI Number |
CTRI/2023/11/060353 [Registered on: 30/11/2023] Trial Registered Prospectively |
| Last Modified On: |
24/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Clinical study on effects of Nutritional supplements versus Pregabalin in Diabetic neuropathy patients |
|
Scientific Title of Study
|
A Randomized controlled study comparing Nutraceuticals and Pregabalin in Diabetic Neuropathy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NARNE KRISHNA GEETHA |
| Designation |
MD General Medicine student |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Room no -1,
Department of General Medicine
Saveetha medical college and hospital
Saveetha Nagar, Thandalam
Chennai
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
|
| Fax |
|
| Email |
narnekg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Sathish Kumar |
| Designation |
Professor and Guide |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Room no-2
Department of Neurology
Saveetha medical college and hospital
Saveetha Nagar, Thandalam
Chennai
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9894923588 |
| Fax |
|
| Email |
sathish2806@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Sathish Kumar |
| Designation |
Professor and Guide |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Room no-2
Department of Neurology
Saveetha medical college and hospital
Saveetha Nagar, Thandalam
Chennai
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9894923588 |
| Fax |
|
| Email |
sathish2806@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha medical college and hospital ,
Saveetha Nagar, Thandalam
Chennai, 602105 |
|
|
Primary Sponsor
|
| Name |
NARNE KRISHNA GEETHA |
| Address |
Saveetha medical college,
Saveetha Nagar, Thandalam
Chennai, 602105 |
| 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 NARNE KRISHNA GEETHA |
Saveetha medical college and hospital |
Room no-1,
Department of General Medicine
Saveetha medical college,
Saveetha Nagar, Thandalam
Chennai, 602105
Kancheepuram
TAMIL NADU |
8885990019
narnekg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E134||Other specified diabetes mellituswith neurological complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Alpha Lipoid Acid , Cynacobalamin ,Folic Acid , Inositol , Chromium picolinate , Pyridoxine hydrochloride , Lutein , Zinc Oxide |
Alpha Lipoid Acid -200mg
Cynacobalamin -1.5mcg
Folic Acid -220mcg
Inositol -100mg
Chromium picolinate -65mcg
Pyridoxine hydrochloride -3mg
Lutein -5mg
Zinc Oxide-22.5mg
Given twice daily for 3 months |
| Comparator Agent |
Pregabalin |
75mg, once daily for 3months |
| Comparator Agent |
Pregabalin,Alpha Lipoid Acid , Cynacobalamin ,Folic Acid , Inositol , Chromium picolinate , Pyridoxine hydrochloride , Lutein , Zinc Oxide
|
Pregabalin 75mg once daily for 3months
Alpha Lipoid Acid -200mg
Cynacobalamin -1.5mcg
Folic Acid -220mcg
Inositol -100mg
Chromium picolinate -65mcg
Pyridoxine hydrochloride -3mg
Lutein -5mg
Zinc Oxide-22.5mg
Given twice daily for 3 months
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female patients aged 30 to 75 years
2. Patients with DPN based on their history and complaints were subjected to clinical examination and monofilament testing along with Michigan Neuropathy Screening Instrument (MNSI)
3. Patients with Type 2 DM with glycosylated hemoglobin [HbA1c] ranging between 6.5% and 10.0%
4. Patients with painful DPN ranging from 1 month to 5 years.
5. Patients who provided informed consent
|
|
| ExclusionCriteria |
| Details |
1. Type 2 diabetes mellitus patients, diagnosed in past 1 year were excluded from the study
2. Patients with type 1 diabetes
3. Patients with any history of hypersensitivity reactions to pregabalin or nutraceuticals to be used in the study population.
4. Patients with hyperthyroidism, hypothyroidism, acromegaly, and Cushing’ syndrome
5. Patients with acute complications of Type 2 diabetes mellitus within the period of 6 months
6. Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Score for Pain |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean Daily Sleep Interference score |
12 weeks |
| Patient Global Impression Change scale |
12 weeks |
| Clinical Global Impression Change scale |
12 weeks |
| Visual Analogue Score for Pain |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="99"
Sample Size from India="99"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
11/12/2023 |
| 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="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 - NO
|
|
Brief Summary
|
This Study is a randomised,open label,parallel group,Multi-arm trial comparing the Nutraceuticals and Pregabalin 75mg in 99 patients with Dibetic Neuropathy that will be conducted in Saveetha medical college in India. The primary outcome measures will be visual analogue score at 12 weeks and Mean daily sleep interference score at 12 weeks.The secondary outcome measures will be Visual Analogue Score at 6 weeks,Patient Global Impression Change scale at 12 weeks and Clinical Global Impression Change Scale at 12 weeks |
|