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CTRI Number  CTRI/2023/07/055834 [Registered on: 28/07/2023] Trial Registered Prospectively
Last Modified On: 27/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Yoga & Naturopathy
Screening 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effectiveness of Integrated Yoga (selected Yoga Postures, Pranayama, & Relaxation technique for reducing pain, stiffness mental discomfort & enhancing the movement of the neck in patients of Cervical spondylosis  
Scientific Title of Study   Therapeutic Role of Integrated Yoga in the Management of Cervical Spondylosis w.s.r. to Antaranga Yoga Yatra Technique 
Trial Acronym  Role of Integrated Yoga Module in the management of neck pain, stiffness, and mental discomfort 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rohit Kumar  
Designation  Ph.D scholar 
Affiliation  Bananas Hindu University  
Address  Department of Kayachikitsa Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University

Varanasi
UTTAR PRADESH
221005
India 
Phone  8127973433  
Fax    
Email  rohit812797@bhu.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr KHHVSS Narasimha Murthy 
Designation  Professor  
Affiliation  Banaras Hindu University  
Address  Department of Kayachikitsa Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University

Varanasi
UTTAR PRADESH
221005
India 
Phone  9415813570  
Fax    
Email  k_narasimhamurthy@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Prof Dr KHHVSS Narasimha Murthy 
Designation  Professor  
Affiliation  Banaras Hindu University  
Address  Department of Kayachikitsa Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University

Varanasi
UTTAR PRADESH
221005
India 
Phone  9415813570  
Fax    
Email  k_narasimhamurthy@yahoo.co.in  
 
Source of Monetary or Material Support  
Faculty of Ayurveda, Sir Sunderlal Hospital (SSH), I.M.S, B.H.U, Varanasi,  
 
Primary Sponsor  
Name  UGC Non Net Fellowship BHU 
Address  OPD in Kayachikitsa and Yoga Chikitsa Laboratories, Dept. of Kayachikitsa, Faculty of Ayurveda, Sir Sunderlal Hospital (SSH), I.M.S, B.H.U, Varanasi, UP, under the supervision of the Supervisor.  
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 
Rohit Kumar   S S Hospital IMS BHU  Sir Sundarlal Hospital, Institute of medical sciences, Banaras Hindu University, Varanasi UTTAR PRADESH
Varanasi
UTTAR PRADESH 		 8127973433

rohit812797@bhu.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M479||Spondylosis, unspecified. Ayurveda Condition: GRIVASTAMBAH/GRIVAHUNDANAM (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Integrated Yoga Module (Procedure Reference: Saraswati, S. S. (1996). Kundalini Tantra. India: Bihar School of Yoga, Procedure details: Integrated Yoga module of 30 miutes(Having selected sukshma vyayama, asana, pranayama,and dhyana))
2Intervention ArmDrugClassical(1) Medicine Name: Vatavidhvansana rasa, Reference: The Ayurvedic Formulary of India PART – I, second edition, National Institute Of Science Communication And Information Resources, CSIR Dr. K.S. Krishnan Marg, New Delhi — 1100012, Pg274, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 125(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: water), Additional Information: -
(2) Medicine Name: Manasamitra vataka , Reference: The Ayurvedic Formulary of India PART – I, second edition, National Institute Of Science Communication And Information Resources, CSIR Dr. K.S. Krishnan Marg, New Delhi — 1100012, Pg189, Route: Oral|, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
3Comparator ArmProcedure-Integrated Yoga Module (Procedure Reference: Saraswati, S. S. (1996). Kundalini Tantra. India: Bihar School of Yoga, Procedure details: Integrated Yoga module of 30 miutes(Having selected sukshma vyayama, asana, pranayama,and dhyana))
(1) Medicine Name: Manasamitra vataka, Reference: The Ayurvedic Formulary of India PART – I, second edition, National Institute Of Science Communication And Information Resources, CSIR Dr. K.S. Krishnan Marg, New Delhi — 1100012, Pg189, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: bd, Duration: 2 Months
(2) Medicine Name: Vatavidhvamsana rasa , Reference: The Ayurvedic Formulary of India PART – I, second edition, National Institute Of Science Communication And Information Resources, CSIR Dr. K.S. Krishnan Marg, New Delhi — 1100012, Pg274, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 125(mg), Frequency: bd, Duration: 2 Months|
 
Inclusion Criteria  
Age From  20.00 Month(s)
Age To  60.00 Month(s)
Gender  Both 
Details  1. In this study, the subject’s ages ranging from 20-60 years were selected.
2. Either sex suffering from cervical pain, disability, and mental discomfort will be registered for the study.
3. Mild and moderate cases of cervical Spondylosis will be considered.
4. Only 150 subjects were selected for this study.
5. - In this study Ayurvedic preparation, Manasamitra vataka, Manasamitra vataka, Vatavidhvamsana rasa, and Panchagavya Ghrita were administered to Cervical Spondylosis persons.

 
 
ExclusionCriteria 
Details  1. The age category of male/female/transgender would be below 20 and above 60.
2. Patients who have any major surgery especially heart, brain, etc.
3. Patients who have previous medical history of hormonal contraceptives.
4. Pregnant women will not be considered in this study.
5. Severe cases of cervical spondylosis will not be considered.
6. Patients sufferings from Diabetes mellitus, renal failure, Paralysis, Parkinson’s disease, severe Anaemia, Malignancy, Leprosy, Bleeding disorder, and other severe diseases shall be excluded from research work.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
VAS(Visual Analog Scale)
NDI(Neck Disability Index)
DASS(Depression Anxiety Stress scale)
 		 18 months
 
 
Secondary Outcome  
Outcome  TimePoints 
DASS(Depression Anxiety Scale)
 		 18 months 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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 4 
Date of First Enrollment (India)   08/08/2023 
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   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The purpose of the study is to evaluate the effectiveness of specific shukshma vyayam Yoga postures pranayama relaxation techniques and medication in cases of cervical spondylosis that have been medically diagnosed For the control and study groups a total of 150 cases can be collected Well administer Ayurvedic medications to the control group Based on the questionnaires viz the Visual Analog Scale VAS Neck Disability Index NDI and Depression Anxiety Stress Scale DASS were used to measure the Neck Disability cervical spondylosis and associated discomfort And three groups will be contrasted for improvement in pain stiffness and neck movements after 15 30 45 and 60 days All Yoga interventions and test variables are non intrusive Still written informed consent will be obtained 
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