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CTRI Number  CTRI/2025/03/083428 [Registered on: 25/03/2025] Trial Registered Prospectively
Last Modified On: 01/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Randomized Clinical Study to compare the effect of Greeva Basti and Nasya Karma with Greeva Pichu and Nasya Karma in Cervical Spondylosis. 
Scientific Title of Study   A Randomized clinical study to compare the effect of Greeva Basti and Nasya Karma with Greeva Pichu and Nasya Karma in Cervical Spondylosis. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
14  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sai Chinmayee T 
Designation  PG Scholar 
Affiliation  Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Center 
Address  Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Center OPD 01 Pipeline road RPC Layout Vijayanagar Bangalore karnataka 560104 India PIPELINE ROAD RPC LAYOUT VIJAYANAGAR 2ND STAGE BENGALURU 560 104
Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Center OPD 01 Pipeline road RPC Layout Vijayanagar Bangalore Karnataka 560104
Bangalore
KARNATAKA
560104
India 
Phone  6238498998  
Fax    
Email  chinmayibhat02@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vinay Kumar KN 
Designation  Professor and HOD 
Affiliation  Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Center 
Address  Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Center OPD 01 Pipeline road RPC Layout Vijayanagar Bangalore karnataka 560104
Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Center OPD 01 Pipeline road RPC Layout Vijayanagar Bangalore Karnataka 560104
Bangalore
KARNATAKA
560 104
India 
Phone  9845617690  
Fax    
Email  knv.gowda@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vinay Kumar KN 
Designation  Professor and HOD 
Affiliation  Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Center OPD 01 Pipeline road RPC Layout Vijayanagar Bangalore karnataka 560104 India 
Address  Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Center OPD 01 Pipeline road RPC Layout Vijayanagar Bangalore karnataka 560104 India
Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Center OPD 01 Pipeline road RPC Layout Vijayanagar Bangalore karnataka 560104 India10 PIPELINE ROAD RPC LAYOUT VIJAYANAGAR 2ND STAGE BENGALURU 560 104
Bangalore
KARNATAKA
560 104
India 
Phone  9845617690  
Fax    
Email  knv.gowda@gmail.com  
 
Source of Monetary or Material Support  
Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Center  
 
Primary Sponsor  
Name  Dr SAI CHINMAYEE T 
Address  SRI KALABYRAVESHWARASWAMY AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE 10 PIPELINE ROAD RPC LAYOUT VIJAYANAGAR 2ND STAGE BENGALURU 560 104 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr KIRAN M GOUD  Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Center Bangalore   OPD 01 Ground Floor Department of PG studies in Panchakarma
Bangalore
KARNATAKA 
9845109556

kiranmgoud@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sri Kalabyraveshwaraswamy Ayurvedic Medical College Hospital and Research Center   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: CERVICAL SPONDYLOSIS, (2) ICD-10 Condition:M479||Spondylosis, unspecified. Ayurveda Condition: VISVACI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-GREEVA BASTI AND NASYA KARMA (Procedure Reference: ASHTANGA HRUDAYA SUTHRA 20, SUSHRUTHA SUTHRA 1, ASHTANGA SUTHRA 22, CHARAKA SIDDI 2, Procedure details: GREEVA BASTI-Moorchita Tila Taila is indirectly heated in water bath and is poured into frame by using cotton swab.When the heated oil gets cooled down, it is taken out of the frame with help of cotton swab. Fresh warm oil is then poured into frame. This is repeated for 30 minutes duration. After 30 minutes, complete oil is taken out from frame with a cotton swab. NASYA KARMA - The patient is made to lie down in supine position Nasya karma will be done by instilling Eight Bindu pramana of Prasar)
(1) Medicine Name: MOORCHITA TILA TAILA, Reference: BHAISHAJYA RATNAVALI JWARA ADHIKARA, Route: Topical, Dosage Form: Taila, Dose: 200(ml), Frequency: od, Duration: 7 Days
(2) Medicine Name: PRASARINYADI TAILA, Reference: YOGA RATNAKARA VATAVYADHI CHIKITHSA, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 7 Days
2Comparator ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Ashtanga hrudaya 22, Procedure details: The patient is made to lie down in supine position Nasya karma will be done by instilling Eight Bindu pramana of Prasarini Taila in avichinna dhara to each nostril using shukti after sthanika abhyanga & nadi sweda to urdhwa jatrugata pradesha followed by dhoomapana with haridra and sukhoshna saindhava jala)
(1) Medicine Name: Prasarini Taila, Reference: Yoga Ratnakara, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Subjects of either gender in between the age group of 18 to 70 years presenting with signs and symptoms of Cervical spondylosis and fit for Greeva Basti and Nasya karma will be selected. 
 
ExclusionCriteria 
Details  Subjects presenting with history of major systemic disorder and history of traumatic infective and neoplastic conditions of spine. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
There is statistically significant difference between the groups on pain stiffness radiation of pain paresthesia vertigo  At baseline 7th day after treatment 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NA 
 
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 
Date of First Enrollment (India)   26/03/2025 
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="3"
Days="5" 
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  

Cervical spondylosis can be considered as Vataja nanatmaja vyadhis occurring above clavicle and can be discussed under different headings Vishwachi, Greevahundana, Greevastambha, Manyastambha. etc.

In order to counteract this condition, two distinct modalities of treatment are employed namely Nasya karma as Antah Parimarjana Chikithsa, Greeva Basti3,4 and Greeva Pichu as Bahi Parimarjana Chikithsa. The term Greeva Basti and Greeva Pichu are evolved from Shiro Basti5 and Shiro Pichu6 respectively. The taila used for these procedures does the Snehana and due to Agni samyoga it causes swedana effect too. Thus these can be considered under the category of Snigdha sweda. Though Greeva Basti evolved from the concept of Shiro Basti is widely practiced as a modality of Snigdha Swedana in the management of Cervical Spondylosis, it has its own limitations as far as covering minimal surface area usually the lower cervical spinal region and difficulty in maintaining the same posture without any neck movement throughout the entire course of treatment. Conventionally, Greeva Pichu which is evolved from the concept of Pichu and Shiro Pichu, can be considered as an alternative modality of Snigdha Swedana over Cervical region by considering its advantage in covering larger surface area as well as the flexibility in postural change during the treatment. And the same will be employed in the management of Cervical Spondylosis. In Charaka Samhita, Tila Taila is mentioned as “Vataghnesha uttamam”7 and in Sushrutha Samhita as “Sarve Anilanashana”8. So Moorchita tila taila9 is employed for both Greeva Basti and Greeva Pichu.

Nasya karma is considered as unique line of treatment in urdhwa jatrugata vikara10. While explaining Nasya Karma yogyas, Charaka mentions ‘Greeva skanda roga’11. Sushrutha mentions ‘Greevaskandorasaam cha balajananartham’12. Prasarini taila13is indicated in vatavyadhi and is described as useful in ‘sarva vatamaya’ and ‘vata jarjaritha nara’ and its utility in the form of Nasya Karma is described as ‘Prabhanjane shreshtam nasyakarmani shasyathe’. So, the same will be employed for Nasya Karma.

Thus, by considering the above factors, a clinical study will be undertaken to evaluate the therapeutic efficacy of Greeva Basti and Nasya karma with Greeva Pichu and Nasya karma in Cervical Spondylosis.

 

   

 
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