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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  
Nil 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M541||Radiculopathy. Ayurveda Condition: VISVACI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-sadyasnehaH, सद्यस्नेहः (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
2Comparator ArmProcedure-manyAbastiH, मन्याबस्तिः (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. 

 
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