| CTRI Number |
CTRI/2024/06/069563 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
24/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of Massage with Roghan-i-Laqwa in Neuropathy |
|
Scientific Title of Study
|
Efficacy of Dalk-i-Mutadil with Roghan-i-Laqwa versus Gabapentin in Distal
Symmetric Polyneuropathy (DSPN) of Diabetic Origin - A
Randomized Controlled Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Irshad Ahmad Wani |
| Designation |
Pg Scholar |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of Ilaj bit Tadbeer, National Institute of Unani Medicine, Kottigepalya, Magadi main road
Bangalore, KARNATAKA
Bangalore
KARNATAKA
560091
India |
| Phone |
8861115610 |
| Fax |
|
| Email |
irshadk0123456789@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohd Nayab |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of Ilaj bit Tadbeer, National Institute of Unani Medicine, Kottigepalya, Magadi main road
Bangalore, KARNATAKA
Bangalore
KARNATAKA
560091
India |
| Phone |
9019080556 |
| Fax |
|
| Email |
nayabdr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohd Nayab |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of Ilaj bit Tadbeer, National Institute of Unani Medicine, Kottigepalya, Magadi main road
Bangalore, KARNATAKA
Bangalore
KARNATAKA
560091
India |
| Phone |
9019080556 |
| Fax |
|
| Email |
nayabdr@gmail.com |
|
|
Source of Monetary or Material Support
|
| NATIONAL INSTITUE OF
UNANI MEDICINE, Kottigepalya, Magadi Main Road, Bangalore
Karnataka 560091 |
|
|
Primary Sponsor
|
| Name |
National Institute of Unani Medicine |
| Address |
National Institute of Unani Medicine, Kottigepalya, Magadi main road
Bangalore KARNATAKA 560091
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Irshad Ahmad Wani |
NATIONAL INSTITUTE OF UNANI MEDICINE |
Department of Ilaj bit Tadbeer OPD 28, Kottigepalya, Magadi Main Road, Bangalore
560091 KARNATAKA
Bangalore
KARNATAKA |
8861115610
irshadk0123456789@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of the Institutional Ethics Committee(IEC)for Biomedical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: E084||Diabetes mellitus due to underlying condition with neurological complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dalk-i- Mutadil/Massage |
Subjects in the test group will be treated by Dalk-i-Mu‘tadil with Roghan-i-Laqwa on the
both legs (from knee to toe) for 20 minutes daily for 30 days. Dalk will be performed with
the fingers and palms of both hands. Approximately 20 ml Roghan will be used in every
sitting/ |
| Comparator Agent |
Drug Gabapentin |
Gabapentin (300 mg/day) will be given for 30 days
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed patients of Distal Symmetrical Peripheral Neuropathy (DSPN) either by
Type 1 or type 2 diabetes mellitus (HbA1c less than 9.5 percent)
Patients of either gender
Patients older than 20 years and less than 60 years of age
|
|
| ExclusionCriteria |
| Details |
ï‚· Pregnancy and lactation.
ï‚· Patients of peripheral neuropathy other than the Diabetic origin.
ï‚· Patients of DSPN due to Diabetes Mellitus having HbA1c more than 9.5%
ï‚· Currently participating in another clinical study in which the subject is or will be
exposed to an investigational or non-investigational drug or device.
ï‚· Pathological state such as cardiovascular diseases, renal diseases, and hepatic
diseases (having abnormal Serum bilirubin, Serum creatinine, Blood urea, AST,
ALT and ECG).
ï‚· Any localized skin lesion over the legs (where integrity of skin is compromised)
ï‚· Unwillingness or inability to comply with the requirements of the protocol. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual analogue scale
Vibration perception threshold (VPT)
ï‚· Michigan neuropathy screening instrument
ï‚· Chronic Acquired Polyneuropathy Patient-Reported Index (CAPPRI)
|
0th, 15th, 30th
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No Secondary Outcome |
N/A |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
08/07/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Purpose: To evaluate the Efficacy of Dalk Mu‘tadil with Roghan-i-Laqwa in DSPN.
Design: Open, Randomized, Controlled Clinical Trial
Study Intervention: Test group: Dalk-i-Mu‘tadil with Roghan-i-Laqwa for 20 min for 30 days Control group: Gabapentin (300 mg/day) for 30 days Main outcome measures: Primary outcome: Visual analogue scale, Vibration perception threshold (VPT) Secondary outcome: Michigan neuropathy screening instrument , Chronic Acquired Polyneuropathy Patient-Reported Index (CAPPRI) |