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CTRI Number  CTRI/2022/06/043112 [Registered on: 09/06/2022] Trial Registered Prospectively
Last Modified On: 02/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   To find the effect of nasal instillation (Nasya karma) of Prabhanjanavimardanam taila in Cervical Spondylosis, which is a chronic degenerative condition that affects the vertebral bodies and intervertebral discs of the neck. 
Scientific Title of Study   Effect of Prabhanjanavimardanam taila Nasya in Cervical spondylosis. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vishnu Sreenivas 
Designation  PG Scholar 
Affiliation  Government Ayurveda College, Thiruvananthapuram 
Address  PG Scholar, Department of Panchakarma, Government Ayurveda College Panchakarma Hospital, Poojappura, Thiruvananthapuram.
Geetha Bhavan, Ayarkunnam P. O., Kottayam- 686564.
Thiruvananthapuram
KERALA
695012
India 
Phone  8281462512  
Fax    
Email  vishnusreenivas000@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pravith N K 
Designation  Associate Professor 
Affiliation  Government Ayurveda College, Thiruvananthapuram 
Address  Department of Kayachikitsa, Government Ayurveda College, Thiruvananthapuram.
K.N. Nivas, Edavanakonam, Kattaikonam P. O., Thiruvananthapuram.
Thiruvananthapuram
KERALA
695007
India 
Phone  9946431132  
Fax    
Email  drnkpravith@gmail.com  
 
Details of Contact Person
Public Query  
Name  VishnuSreenivas 
Designation  PG Scholar 
Affiliation  Government Ayurveda College, Thiruvananthapuram 
Address  PG Scholar, Department of Panchakarma, Government Ayurveda College Panchakarma Hospital, Poojappura, Thiruvananthapuram.
Geetha Bhavan, Ayarkunnam P. O., Kottayam- 686564.
Thiruvananthapuram
KERALA
695012
India 
Phone  8281462512  
Fax    
Email  vishnusreenivas000@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda College Panchakarma Hospital, Poojappura, Thiruvananthapuram. 
 
Primary Sponsor  
Name  Government Ayurveda College Panchakarma Hospital Poojappura Thiruvananthapuram 
Address  Government Ayurveda College Panchakarma Hospital, Poojappura, Thiruvananthapuram- 695012 
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 
Vishnu Sreenivas  Government Ayurveda College Panchakarma Hospital, Poojappura, Thiruvananthapuram  Department of Panchakarma, Government Ayurveda College Panchakarma Hospital, Poojappura, Thiruvananthapuram- 695012.
Thiruvananthapuram
KERALA 		 8281462512

vishnusreenivas000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Government Ayurveda College, Thiruvananthapuram  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: AVABAHUKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-aBya~ggaH, अभ्यंग  (Procedure Reference: Ashtanga Hridaya, Procedure details: Application of Tila taila and massaging over face, neck, chest and upper back of the body.)
(1) Medicine Name: Tila Taila, Reference: Ashtanga Hridaya, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 7 Days
2Intervention ArmProcedure-nADIsvedaH, नाडीस्वेदः (Procedure Reference: Ashtanga Hridaya, Procedure details: Giving vapourisation over face, neck, chest and upper back after tieing the eyes with a soft towel.)
3Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् Pradhan Karma(Procedure Reference: Ashtanga Hridaya, Procedure details: Nasal administration of medicated oil.)
(1) Medicine Name: PRABHANJANAVIMARDANAM TAILA-MRIDU PAKA, Reference: SAHASRAYOGA, Route: Nasal, Dosage Form: Taila, Dose: 8(ml), Frequency: od, Duration: 7 Days
4Intervention ArmProcedure-dhUmapAnam, धूमपानम् (Procedure Reference: Ashtanga Hridaya, Procedure details: Nasal inhalation of medicated smoke.)
(1) Medicine Name: HARIDRADI DHUMA VARTI, Reference: ASHTANGA HRIDAYA, Route: Nasal, Dosage Form: Varti/ Suppository, Dose: 18(NA), Frequency: od, Duration: 7 Days
5Intervention ArmProcedure-kavalaH, कवलः (Procedure Reference: Ashtanga Hridaya, Procedure details: Gargling of medicine.)
(1) Medicine Name: LUKEWARM WATER, Reference: ASHTANGA HRIDAYA, Route: Oral, Dosage Form: Not Applicable, Dose: 20(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Participants of both sexes between 30-60 years.
2)Participants satisfying the criteria as per Oswestry Diability Index for Neck Pain. 
 
ExclusionCriteria 
Details  1)Participants who are unfit for Nasya karma.
2)Participants with recent history of cervical spine injury. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Changes in following variables: Neck stiffness and pain, occipital headache, pain in shoulder or arms, range of movements, numbness, tingling sensation or weakness in upper limbs and functional assessments identified by Oswestry Disability Index for Neck Pain and Visual Analogue Scale.  8th day and 14th day 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/06/2022 
Date of Study Completion (India) 25/05/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 25/05/2023 
Estimated Duration of Trial   Years="1"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Cervical spondylosis is a chronic degenerative condition of the cervical spine that affects the vertebral bodies and intervertebral discs of the neck as well as the contents of spinal canal. Now a days, it is encountered in young and middle-aged people, due to sedentary habits and increase in over exerting working conditions. There is significant degenerative changes seen in 70% of women at the age of 65 and 95% of men at the age of 60. In Ayurveda, cervical spondylosis can be clinically compared to Apabahuka, Viswachi or Greevastambha, where nasya could be the effective and economical treatment modality. Cervical spondylosis is a dhatukshayajanya vatavikara. Prabhanjanavimardanam Taila, mentioned in the Tailaprakarana of Sahasrayoga, is indicated for ashiti vatarogas as pana, abhyanga, nasya and vastikarma. Prabhanjanavimardanam taila act as vatakapha shamana, sothahara, balya and rasayana. Considering both the dosa kopa and vitiated dosa sthana, nasya karma with Prabhanjanavimardanam Taila is selected. The data will be collected through observation, Visual analogue scale and Oswestry disability index for neck pain. After collecting baseline data, detailed examination will be done using clinical case proforma. Nasya will be done at evening (4-5pm), in a dose of 8 bindu (4ml) in each nostril for 7 days. Changes in neck stiffness, pain, occipital headache, pain in shoulder, range of movements, numbness, weakness in upper limbs and functional assessment will be analysed before treatment, after treatment on the 8th day and follow up on 14th day after treatment.  
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