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CTRI Number  CTRI/2024/12/078809 [Registered on: 31/12/2024] Trial Registered Prospectively
Last Modified On: 31/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Ayurvedic trial for treatment of Greeva Sandhigatavata (Cervical Spondylosis) 
Scientific Title of Study   Comparative study to evaluate efficacy of Ksheerbala Taila Greeva Basti and Matra Basti in the management of Greeva Sandhigatavata (Cervical Spondylosis )  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pranay Singh 
Designation  PG Scholar 
Affiliation  Chaudhary Brahm Prakash Ayurved Charak Sansthan 
Address  Room No-123, PG Department of Panchakarma , Chaudhary Brahm Prakash Ayurved Charak Sansthan ,Khera Dabar , Najafgarh

South West
DELHI
110073
India 
Phone  8291215114  
Fax    
Email  singhpranay037@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pankaj Kumar Katara  
Designation  Assistant Professor 
Affiliation  Chaudhary Brahm Prakash Ayurved Charak Sansthan 
Address  Room No -144, PG Department of Panchakarma , Chaudhary Brahm Prakash Ayurved Charak Sansthan ,Khera Dabar , Najafgarh

South West
DELHI
110073
India 
Phone  9910430500  
Fax    
Email  drpankajkatara@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pankaj Kumar Katara  
Designation  Assistant Professor 
Affiliation  Chaudhary Brahm Prakash Ayurved Charak Sansthan 
Address  Room No -144, PG Department of Panchakarma , Chaudhary Brahm Prakash Ayurved Charak Sansthan ,Khera Dabar , Najafgarh

South West
DELHI
110073
India 
Phone  9910430500  
Fax    
Email  drpankajkatara@gmail.com  
 
Source of Monetary or Material Support  
Chaudhary Brahm Prakash Ayurved Charak Sansthan,Khera Dabar, Najafgarh , New Delhi , India Pincode -110073 
 
Primary Sponsor  
Name  Chaudhary Brahm Prakash Ayurved Charak Sansthan 
Address  KHERA DABAR , NAJAFGARH,NEW DELHI 110073 
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 Pankaj Kumar Katara  Chaudhary Brahm Prakash Ayurved Charak Sansthan  OPD and IPD PG Department of Panchakarma ,Chaudhary Brahm Prakash Ayurved Charak Sansthan ,Khera Dabar , Najafgarh ,New Delhi 110073
South West
DELHI 		 9910430500

drpankajkatara@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee -Chaudhary Brahm Prakash Ayurved Charak Sansthan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M478||Other spondylosis. Ayurveda Condition: GRIVASTAMBAH/GRIVAHUNDANAM (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: Charak Siddhisthana Snehavyapadsiddhiadhyay (Chapter 4)/54, Procedure details: Dose of Administration -72 ml Frequency of Administratiion-Once a day Route of Administration – Rectal Duration of Administration -10 Days Before administration of Basti , Sarvanga Abhyanga with Ksheerbala oil is done to the whole body for 10 minutes. Thereafter, Sarvanga Vashpa Swedana is done for 10 minutes or as per the disease condition & prakriti of patients, then warm the Ksheerbala oil at 40 to 45 degree celcius. The quantity of lukewarm oil to be taken for each patient is 72 ml as described in classical texts.Keep the patient in left lateral position on Basti table . Fill the syringe with warm oil . Remove the air from syringe as well as from the catheter. Lubricate the catheter with the oil & insert through anus very gently. Push the oil with neutral pressure .After removing catheter do Tadana karma (Tapping ) on loins or buttock region and ask patient to remain in the same position for 5-10 minutes )
(1) Medicine Name: KsheerBala Taila, Reference: Sahasrayogam Taila Prakarna, Route: Rectal, Dosage Form: Taila, Dose: 72(ml), Frequency: od, Duration: 10 Days
2Intervention ArmProcedure-grIvAbastiH, ग्रीवाबस्तिः (Procedure Reference: Charak Chikitsa Vatavyadhiadhyay(Chapter 28)/104-105, Procedure details: Frequency of administration - once a day Duration of administration -10 days Route of administration -Topical Dough is made from Masha powder by adding warm water. A round pit is prepared of about 10-15 cm long, thickness of 3 cm and height of 5 cm.The patient is then asked to lie down in prone position with forehead resting on flexed arms. Prepared dough is fixed on the back of the neck of the patient in circular shape for which plastic ring will be used. Proper sealing is ensured to avoid leakage of oil. Then Ksheerbala oil would be made warm and after ensuring the tolerable temperature oil it will be poured inside the tank along the sides. The temperature of the oil should be maintained at 40 to 48 degree Celcius by replacing a small quantity with sponge after reheating. Procedure should be done for 30 minutes for a period of 10 days.)
(1) Medicine Name: Ksheerbala Taila, Reference: Sahasrayogam Taila Prakarna, Route: Topical, Dosage Form: Taila, Dose: 500(ml), Frequency: od, Duration: 10 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients presenting in OPD and IPD of CBPACS with clinical features of GreevaSandhigata Vata as GreevaSandhiShula, , GreevaSandhiShotha, , GreevaSandhi Prasarna Akunchanayohopravritti Savedana  
 
ExclusionCriteria 
Details  Patients reporting with any of the following-
1. Any acute condition of cervical spine like, injury, fractures.
2. Acute or chronic infections of spine
3. Carcinoma of cervical spine
4. Rheumatoid Arthritis, SLE, Ankylosing Spondylosis.
5. Any recent cervical surgery, implanted instrumentation or prosthesis.
6. Pain in cervical region radiating to unilateral or bilateral upper limbs
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
KsheerBala Taila Greevabasti may be more effective than KsheerBala Taila Matrabasti in the management of Greevasandhigata Vata(Cervical Spondylosis) in improving the Visual analogue scale (VAS) Score and Neck Disability Index (NDI) Score.  0,10th,30th day. 
 
Secondary Outcome  
Outcome  TimePoints 
KsheerBala Taila Greevabasti may be more effective than KsheerBala Taila Matrabasti in the management of Greevasandhigata Vata(Cervical Spondylosis) in improving the associated symptoms of Greevasandhigata Vata(Cervical Spondylosis) as GreevaSandhiShula (Pain in cervical region ),
GreevaSandhiShotha (Swelling in the cervical region ),
GreevaSandhi Prasarna Akunchanayohopravritti Savedana (Restriction in range of motion of cervical region ).  		 0,10th,30th day. 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   14/01/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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
Brief Summary   The study is a comparative study to compare the effect of KsheerBala Oil Greevabasti with KsheerBala Oil Matrabasti in the management of Greevasandhigatavata( Cervical Spondylosis). In one group KsheerBala Oil Greevabasti will be administered for 10 days with follow up on 30th day .In another group KsheerBala Oil Matrabasti will be administered for 10 days with follow up on 30th day .The trial will be conducted in Chaudhary Brahm Prakash Ayurved Charak Sansthan with outcome,  KsheerBala Oil Greevabasti may show better efficacy than KsheerBala Oil Matrabasti  in the management of Greevasandhigatavata( Cervical Spondylosis) in improving the associated symptoms of Greevasandhigatavata( Cervical Spondylosis). 
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