| CTRI Number |
CTRI/2025/12/098421 [Registered on: 03/12/2025] Trial Registered Prospectively |
| Last Modified On: |
02/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani
Other (Specify) [Hijama Nariya (Fire Cupping)] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment of Sciatica in Unani Medicine |
|
Scientific Title of Study
|
A Comparative Clinical Study to Evaluate the Efficacy of Hijama Nariya and Transcutaneous Electrical Nerve Stimulation(TENS) in the Treatment of Irq al Nasa(Sciatica) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arshi Akhtar |
| Designation |
PG Scholar |
| Affiliation |
State Unani Medical College and Hospital |
| Address |
Department of Ilaj-bit-Tadabeer, State Unani Medical College and Hospital, Old GT Road Himmatganj, Prayagraj
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
9889291244 |
| Fax |
|
| Email |
akhtararshi.94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Nusrat Parveen |
| Designation |
Professor |
| Affiliation |
State Unani Medical College and Hospital |
| Address |
Department of Ilaj-bit-Tadabeer, State Unani Medical College and Hospital, Old GT Road Himmatganj, Prayagraj
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
7906813040 |
| Fax |
|
| Email |
nusratparveen12755@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arshi Akhtar |
| Designation |
PG Scholar |
| Affiliation |
State Unani Medical College and Hospital |
| Address |
Department of Ilaj-bit-Tadabeer, State Unani Medical College and Hospital, Old GT Road Himmatganj, Prayagraj
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
9889291244 |
| Fax |
|
| Email |
akhtararshi.94@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Unani Medical College and Hospital, Prayagraj-211016 Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
State Unani Medical College and Hospital |
| Address |
Old GT Road Himmatganj Prayagraj- 211016, Uttar Pradesh, India |
| 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 |
| DrArshi Akhtar |
State Unani Medical College and Hospital |
Department of Ilaj-bit-Tadabeer, State Unani Medical College and Hospital,Old GT Road Himmatganj, Prayagraj-211016
Allahabad
UTTAR PRADESH |
9889291244
akhtararshi.94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M544||Lumbago with sciatica, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hijama Nariya (Fire Cupping) |
The affected area will be kept uncovered for the purpose of Hijama Nariya, and the patient will be kept in the prone position. Cups of size No. 3 will be used. Four cups will be applied. The cups will be placed in the lumbosacral region and along the course of the sciatic nerve. The intervention will be performed for 10 minutes in each sitting. A total of 14 sittings will be given on alternate days. The duration of assessment will be 28 days. The duration of the study will be 18 months. Baseline assessment will be conducted through clinical assessment of the patient on day 0. Follow-up will be performed on the 14th and 28th day. |
| Comparator Agent |
Transcutaneous Electrical Nerve Stimulation (TENS) |
Burst TENS will be applied on the lower back and up to the affected leg for 10 minutes, negative electrodes will be placed distally to the positive electrodes, and the positive electrodes will be located as close to the representative spinal segment as possible. The negative electrodes will be located at the dermatome distribution of the involved nerve, over the painful site, proximal or distal to the pain site, segmentally related myotomes, and trigger points. In this modality, high frequency, short pulse, high intensity electric current will be used. The intervention will be performed for 10 minutes in each sitting. A total of 14 sittings will be given on alternate days. The duration of assessment will be 28 days. The duration of the study will be 18 months. Baseline assessment will be conducted through clinical assessment of the patient on day 0. Follow-up will be performed on the 14th and 28th day. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients between the ages of 20-60 years of both genders with mild to moderate cases.
Patients with a clinical diagnosis of Irq al-Nasa (Sciatica), based on the following diagnostic criteria.
Pain in the lower back radiating up to the buttocks and lower leg, mostly unilateral.
Pain increases in the morning and during movements.
Pain increases on SLR Test.
Patients willing to give written informed consent and comply with the protocol. |
|
| ExclusionCriteria |
| Details |
Pregnancy and lactation.
Patients with Cardiovascular diseases and bone fracture.
Patients with severe systemic diseases like Tumour, Cancer, etc.
Known case of Epilepsy.
Patient with Pacemaker.
Patient taking analgesic drug treatment in past one week. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
SLR Test.
Visual Analogue Scale (VAS) for pain assessment. |
SLR Test assessed at baseline,2nd week & 4th week.
Visual Analogue Scale assessed at baseline,2nd week & 4th week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in SF36 questionnaire. |
Change in SF36 questionnaire assessed at baseline & 4th week. |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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)
|
19/12/2025 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- 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 - Proposals should be directed to [akhtararshi.94@gmail.com].
- For how long will this data be available start date provided 01-12-2025 and end date provided 31-01-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The study is an open-label randomized clinical trial comparing the efficacy of Hijama Nariya (fire cupping therapy) with Transcutaneous Electrical Nerve Stimulation (TENS) in 86 patients aged 20–60 years suffering from mild to moderate Irq-al-Nasa (sciatica). Patients are equally divided into two groups, each receiving 14 alternate-day sittings of 10 minutes over 28 days, with pain assessed by Visual Analogue Scale (VAS) and Straight Leg Raising Test (SLRT) as primary outcomes and quality of life measured by SF-36 as the secondary outcome. The study aims to scientifically validate the traditional Unani regimen of Hijama Nariya against the modern physiotherapeutic modality TENS in reducing sciatic pain and improving functional status, with assessments at baseline, 14th, and 28th day, and results to be analyzed using intention-to-treat principles. |