| CTRI Number |
CTRI/2024/12/078807 [Registered on: 31/12/2024] Trial Registered Prospectively |
| Last Modified On: |
20/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani
Other (Specify) [Amal-e-Kai] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment of Sciatica by Amal-e-kai(Cauterisation) |
|
Scientific Title of Study
|
Efficacy of Amal-e-kai in alleviating the pain of irqunnasa- A randomised 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. Dwarakeesha Chatrappa |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Unani Medicine, Bangalore |
| Address |
Department of Ilaj bit Tadbeer, National Institute of Unani Medicine, Kottigepalya, Magadi main road, Bangalore
Bangalore
KARNATAKA
560091
India |
| Phone |
6363181751 |
| Fax |
|
| Email |
dwarakish2016@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Mohd Nayab |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Unani Medicine, Bangalore |
| Address |
Department OF Ilaj bit Tadbeer, National Institute of Unani Medicine, Kottigepalya, Magadi main road, Bangalore
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, Bangalore |
| Address |
Department OF Ilaj bit Tadbeer, National Institute of Unani Medicine, Kottigepalya, Magadi main road, Bangalore
Bangalore
KARNATAKA
560091
India |
| Phone |
9019080556 |
| Fax |
|
| Email |
nayabdr@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Unani Medicine Magadi main road Kottigepalya Bangalore 560091 Karnataka |
|
|
Primary Sponsor
|
| Name |
National Institute of Unani Medicine |
| Address |
NATIONAL INSTITUTE OF UNANI MEDICINE, MAGADI MAIN ROAD, KOTTIGEPALYA, BANGALORE 560091 KARNATAKA INDIA |
| 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 Dwarakeesha Chatrappa |
National Institute of Unani Medicine, Bangalore |
OPD 28, Department of Ilaj bit Tadbeer, National Institute of Unani Medicine, Kottigepalya, Magadi main road, Bangalore-560091
Bangalore
KARNATAKA |
6363181751
dwarakish2016@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of the Institutional Ethics Committe (IEC) for Biomedical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, (2) ICD-10 Condition: G544||Lumbosacral root disorders, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amal-e-Kai |
In test group, to make the patient comfortable in prone position and the amal-e-kai is done in four points along the course of the respective sciatic nerve viz, over the hip joint postero-laterally, just above the knee joint line postero-laterally, 4cm above the lateral malleolus and lateral aspect of the little toe, done on 1st, 8th and 15th day(3 sittings in 15days) |
| Comparator Agent |
TENS(Transcutaneous Electrical Nerve Stimulation) |
in control group TENS is done over lower back and course of sciatic nerve over 20mins of duration on 1st, 8th and 15th day(3 sittings in 15days) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.clinically diagnosed patients if sciatica
2.patient having pain in range of 3 to 7 on VAS
3.patient willing to take part in the study |
|
| ExclusionCriteria |
| Details |
1.pregnant and lactating women
2.systemic illness such as cancer, DM, epilepsy,
cardiac, liver, kidney and pulmonary diseases
3.Spinal injury and deformity(congenital/acquired)
4.who fail to give consent for trial |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS(VISUAL ANALOGUE SCALE) |
At baseline, 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SBI(Sciatica Bothersomeness Index) |
At baseline, 2 weeks |
|
|
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)
|
10/02/2025 |
| 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="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
|
Purpose- Efficacy of Amal-e-Kai in alleviating the pain of Irqunnasa(Sciatica)- A randomised controlled clinical trial
Intervention- In test group, to make the patient comfortable in prone position and the amal-e-kai is done in four points along the course of the respective sciatic nerve viz, over the hip joint postero-laterally, just above the knee joint line postero-laterally, 4cm above the lateral malleolus and lateral aspect of the little toe, done on 1st, 8th and 15th day(3 sittings in 15days) control- In control group TENS is done over lower back and course of sciatic nerve over 20mins of duration on 1st, 8th and 15th day(3 sittings in 15days)
Study duration: 1year 6months
Main outcome measure:
Primary outcome: VAS (Visual Analogue Scale)
Secondary outcome: SBI (Sciatica Bothersomeness Index)
|