| CTRI Number |
CTRI/2026/02/104922 [Registered on: 26/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Neck pain management with combined effect of physiotherapy and traditional lemon bolus massage. |
|
Scientific Title of Study
|
To evaluate the add-on effect of therapeutic ultrasound with Jambeera pinda sweda in cervical radiculopathy-A comparative study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bismi Naushad |
| Designation |
PG scholar |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital,Chennai,Tamilnadu |
| Address |
PG Department of Panchakarma,Sri Jayendra Saraswathi Ayurveda College and Hospital,Nazrathpet,Chennai,Thiruvallur
Thiruvallur TAMIL NADU 600123 India |
| Phone |
8606139600 |
| Fax |
|
| Email |
bismibijina@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrChitta Ranjan Das |
| Designation |
Head of Department |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital,Chennai,Tamilnadu |
| Address |
PG Department of Panchakarma,Sri Jayendra Saraswathi Ayurveda College and Hospital,Nazrathpet,Chennai,Thiruvallur
Thiruvallur TAMIL NADU 600123 India |
| Phone |
9444123506 |
| Fax |
|
| Email |
drcrdas@sjsach.org |
|
Details of Contact Person Public Query
|
| Name |
Bismi Naushad |
| Designation |
PG scholar |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital,Chennai,Tamilnadu |
| Address |
PG Department of Panchakarma,Sri Jayendra Saraswathi Ayurveda College and Hospital,Nazrathpet,Chennai,Thiruvallur
Thiruvallur TAMIL NADU 600123 India |
| Phone |
8606139600 |
| Fax |
|
| Email |
bismibijina@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Jayendra Saraswathi Ayurveda College and Hospital,Nazrethpetai,Chennai-Thiruvallur ,600123 |
|
|
Primary Sponsor
|
| Name |
Bismi Naushad |
| Address |
Sri Jayendra Saraswathi Ayurveda College and Hospital,Nazarethpet,Chennai,600123 |
| 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 |
| DrBismi Naushad |
Sri Jayendra Saraswathi Ayurveda college and hospital |
ROOM NO 10 Department of Panchakarma
OP and IPD of PANCHAKARMA
Sri Jayendra Saraswathi Ayurveda College and Hospital ChennaiTamilnadu,INDIA
600123
Chennai TAMIL NADU |
8606139600
bismibijina@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Sri Jayendra Saraswathi Ayurveda College and Hospital |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M541||Radiculopathy. Ayurveda Condition: VISVACI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | sa~gkarasvedaH, संकरस्वेदः | (Procedure Reference: , Procedure details: Abhyanga (external oleation) performed with Moorchitha tila Taila all over the upper limb, shoulders & scapular region for about 10 minutes & then Talam is applied on centre of the head with 10 mL Moorchitha tila Taila & Rasnadi choorna.Jambeera pinda sweda will be done for 20 min .After procedure mild massage anf thalam removed & rasnadi choorna applied.After a gap of 6 hr TUS is done .
A Technomed Electroson 608 US device will be applied in continuous mode, 1-MHz frequency (provides deep tissue penetration up to 5cm) , & 1.5-W/cm² intensity over the neck surface area. The headpiece area of the device was 5 cm². The headpiece is placed on the para-vertebral muscles & trapezius muscle in the posterolateral zone of the neck. The application is performed with the head of the device positioned perpendicular to & in full contact with the skin for 15 min using Diclofenac gel & a continuous circular motion for 7 consecutive days.
)
|
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Neck stiffness and pain
Referred or radiating pain along the upper limb, shoulder or scapular region
Motor deficit Weakness of deltoid, biceps, triceps, depending on root involved.
Sensory loss numbness, tingling or paraesthesia.
Any 3 out of 4 positives
Spurling s test
Distraction test
Upper limb tension test
Cervical rotation less than 60 degree
MRI findings
Disc herniation or protrusion
Neural foramen narrowing
Nerve root compression or deviation
Osteophyte induced nerve root impingement
|
|
| ExclusionCriteria |
| Details |
Uncontrolled Diabetes mellitus (HbA1c over 7)
Uncontrolled hypertension 140upon 100mmhg
Large disc extrusion or sequestration
Marked spinal canal indentation or compression greater than 50 percent
Inflammatory rheumatic disease
Malignancy
History of surgical intervention on the neck region
Patients in which TUS is contraindicated and Swedana
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effectiveness of Jambeera pinda sweda alone and in combination with therapeutic ultrasound in the management of cervical radiculopathy using DVPRS and Cervical radiculopathy impact scale.
|
assessment will be done on 7th and 14th day of treatment.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the effectiveness of Jambeera pinda sweda alone and in combination with therapeutic ultrasound in the management of cervical radiculopathy using DVPRS and Cervical radiculopathy impact scale.
|
7th and 14th day |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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 |
|
Date of First Enrollment (India)
|
20/03/2026 |
| 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="2" Months="0" 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
|
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Brief Summary
|
Cervical radiculopathy (CR) is a condition where the nerve root of the cervical spine is compressed or impaired which causes pain and symptoms to radiate beyond neck region towards the arms, scapular region and shoulders.Less frequent than lumbar radiculopathies, cervical radiculopathy occurs at prevalence rate of 1.2 to 5.8 per 1000 persons. In younger patients, typically in their 30s and 40s, disc trauma and herniation are the most common cause of impingement.Cervical radiculopathy has similarity in presentation with Vishwachi, a Vatavyadhi wherein the Vayu afflicts the Kandaras extending from the Bahu Prishta to Hasta causing Karmakshaya of the Bahu. As Greeva as its Adhishtana which is a Kapha Sthana, the initial phase is associated with Kaphavarana, (stiffness is dominant) followed by a chronic stage of Dhatukshaya. Therapeutic ultrasound is a technique of deep tissue heating where sound waves are utilized to elevate tissue temperature. The heat shock response inhibits the inflammatory pathway, and pain is reduced through the pain gate mechanism. The thermal and mechanical effects promote muscle relaxation, improve circulation, and reduce pain and stiffness of the cervical muscles. It also promotes collagen synthesis and fibroblast activity, thereby stimulating soft tissue repair and relieving pain. Jambeera Pinda Sweda, a modified Sankara Sweda, using a bolus prepared with lemon (Citrus limon), turmeric, and rock salt, delivers both thermal and pharmacological effects. Jambira has Amla Rasa, Usha Virya, Laghu Thikshna guna which causes Shamana of Vata Kapha Dosha. Lemon contains essential oils like limonene and Ascorbic acid, which have shown anti-inflammatory, antioxidant, and fibroblast-stimulating properties in experimental studies. These effects align with the mechanisms by which ultrasound therapy promotes musculoskeletal healing. Both methods enhance microcirculation, reduce inflammation, and support connective tissue repair, though one uses electromagnetic energy while the other uses herbal heat application. Several studies prove the effect of Jambeera pinda sweda and TUS in cervical radiculopathy but no studies have been done to evaluate their combined effect. This study is of immense value to the Ayurvedic fraternity as it evaluates Jambeera Pinda sweda as a standalone therapy and in combination with ultrasound therapy thereby examining the impact of contemporary interventions on traditional wisdom. |