| CTRI Number |
CTRI/2022/01/039465 [Registered on: 17/01/2022] Trial Registered Prospectively |
| Last Modified On: |
17/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of Uttarbhaktika Snehana and Manya Basti in the Management of Cervical Pain. |
|
Scientific Title of Study
|
A Non-Randomised Clinical Trial to Evaluate the Efficacy of Uttarbhaktika Snehana and
Manya Basti in the Management of Cervical Radiculopathy |
| Trial Acronym |
CR |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manoj Shamkuwar |
| Designation |
Head of Department |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Department of Panchakarma, Room No 3,Ayurvedic and Unani Tibbia College and Hospital, Ajmal Khan Road, Karol Bagh, New Delhi
Central DELHI 110005 India |
| Phone |
9423039441 |
| Fax |
|
| Email |
manoj_1873@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Manoj Shamkuwar |
| Designation |
Head of Department |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Department of Panchakarma, Room No 3,Ayurvedic and Unani Tibbia College and Hospital, Ajmal Khan Road, Karol Bagh, New Delhi
Central DELHI 110005 India |
| Phone |
9423039441 |
| Fax |
|
| Email |
manoj_1873@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Divya Panchal |
| Designation |
MD Scholar |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Department of Panchakarma, P.G.Room,Ayurvedic and Unani Tibbia College and Hospital, Ajmal Khan Road, Karol Bagh, New Delhi
Central DELHI 110005 India |
| Phone |
9958709174 |
| Fax |
|
| Email |
divyapanchal95@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Department of Panchakarma, Ayurvedic and Unani Tibbia College and Hospital, Ajmal Khan Road, Karol Bagh, New Delhi 110005 |
| 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 |
| Dr Divya Panchal |
Ayurvedic and Unani Tibbia College and Hospital |
Department of Panchakarma,Ayurvedic and Unani Tibbia College and Hospital, Ajmal Khan Road, New Delhi 110005 Central DELHI |
9958709174
divyapanchal95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Ayurvedic and Unani Tibbia College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 | Comparator Arm | Procedure | - | sadyasnehaH, सदà¥à¤¯à¤¸à¥à¤¨à¥‡à¤¹à¤ƒ | (Procedure Reference: Astanga Hridaya Sutrasthana 16/20, Procedure details: Uttarbhaktika Snehapana with Rasana Ghrita orally after the first meal of the day for 21 days in Group A) (1) Medicine Name: Rasana ghrita, Reference: Charaka chikitshasthana kasa adhyaya 18/43-46, Route: Oral, Dosage Form: Ghrita, Dose: 40(ml), Frequency: od, Duration: 21 Days | | 2 | Comparator Arm | Procedure | - | manyAbastiH, मनà¥à¤¯à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: charaka sutrasthana 14, Procedure details: Manya Basti with Tila taila locally for 21 days in Group B)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Those who are diagnosed with the features of cervical herniated disc or bone spur is impeding a nerve root in the neck through MRI finding with a feature like difficulty in movements of the arm, stiffness in hand, clumsy movements of fingers, neck pain, radiation of pain, stiffness, weakness, paresthesia, vertigo, tenderness over cervical, movements of the neck restricted.
2. Patients with age group of 18-55 years.
3. Willing and able to participate in the study for 1 month.
|
|
| ExclusionCriteria |
| Details |
1. Those who are not willing to participate in the study.
2. Pregnancy and Lactating mother.
3. History of cervical instability, cord compression, central pain syndrome (e. g. Fibromyalgia), evidence of CNS involvement, known history of high- level spinal cord injury, traumatic injuries to upper limb and cervical spine, limitation of glenohumeral joint, elbow joint or wrist joint, evidence of malignancy.
4. Any medical red flag. (i.e., spinal tumor, fracture, metabolic disease, RA, osteoporosis, spinal infection etc).
5. Patients having co – morbidities like hypertension (systolic >160 and diastolic >100 mm of Hg) despite of antihypertensive agents and diabetic mellitus (According to WHO, fasting plasma glucose ≥ 7.0mmol/l (126mg/dl) or 2–h plasma glucose ≥ 11.1mmol/l (200mg/dl), active case of tuberculosis.
6. Those who have completed participation in any other clinical trial drugs or their ingredients in one -month period.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess the effect of Uttarbhaktika Snehana with Rasna Ghrita in the patients of Cervical Radiculopathy.
2. To compare the efficacy of Uttarbhaktika Snehana and Manya Basti with the help of neck disability index, foraminal compression (Spurling’s test), distraction test, upper limb tension test (brachial plexus tension or Elvey test), cervical rotation test.
3. To provide comparative analysis of effect of Uttarbhaktika Snehana and Manya Basti in Cervical Radiculopathy. |
Check the efficacy of Uttarbhaktika Snehana and Manya Basti with the help of neck disability index, foraminal compression (Spurling’s test), distraction test, upper limb tension test (brachial plexus tension or Elvey test), cervical rotation test
[time frame:baseline or 0th day, 8th and 16th and 30th day] |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Evaluate the therapeutic efficacy of Uttarbhaktika Snehana.
2.Evaluate the therapeutic efficacy of Manya Basti.
3. Assessment of Uttarbhaktika Snehana and Manya Basti |
1. Parameters like visual analogue scale on rest and activity, range of motion by a goniometer, Nerve conduction velocity test (NCV)
[Time frame:baseline and 30th day]
2.HbA1c,LFT,KFT, Lipid profile
[Time frame: baseline and 30th day] |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/03/2022 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
After recruitment, the publication will be done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cervical
radiculopathy is a neurologic condition characterized by dysfunction of a
cervical spinal nerve, the roots of the nerve, or both. It usually presents
with pain in the neck and one arm, with a combination of sensory loss, loss of
motor function, or reflex changes in the affected nerve-root distribution. The
symptoms include
neck pain, radiation of pain, stiffness, weakness, paresthesia,
clumsy finger movements, vertigo, tenderness over cervical, movements of the
neck restricted etc. It is commonly called a "pinched nerve,"
occurs when a nerve in the neck is compressed or irritated where it branches
away from the spinal cord. It is often caused by "wear and tear"
changes that occur in the spine. Because of present-day lifestyles, food,
habits, excessive stress-strain and anxiety more people are getting these
problems. In younger people, it is most often caused by a sudden injury that
results in a herniated disk. In some cases, however, there is no traumatic
episode associated with the onset of symptoms. It is associated with movement
impairment of the upper limbs in 68% of the cases, scapular pain in 52.5% of
cases, paresthesia in 45.5% of the cases, chest pain in 17.8% of the cases and
headache in 9.7% of the cases, among others.
It is a common
disease affecting the middle and old age group of both sex and is prevalent
worldwide with a lifetime incidence of 40-60%. The most affected age group is
30-70 years. In daily wage labourers and some occupational postures
like in teachers, coolies, drivers, tailors are the commonest causes of neck
pain. In males the prevalence is 100% by age 70yrs, 96% in women older than 70
yrs. 60-70% women and 85% of men show changes related with cervical spondylosis
by the age of 45yrs.
Viswachi
is a disease which exhibits weakness or sensational disturbances, disturbances
of the movements of the hand. Vishwachi is a disease affecting the neck and
upper extremities having the signs and symptoms like Ruka, Stambha, Toda,
Karmakshaya and Chestapaharana of Bahu. |