FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/12/078683 [Registered on: 27/12/2024] Trial Registered Prospectively
Last Modified On: 17/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A clinical study to evaluate the effect of mahamasha medicated oil greeva basti with pratimarsha nasya in cervical spondylosis 
Scientific Title of Study   A clinical study to evaluate the effect of mahamasha taila greeva basti with partimarsha nasya in vishwachi w.s.r. to 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 Archana A S 
Designation  PG Scholar 
Affiliation  Sri Dharamasthala Manjunatheshwara College Of Ayurveda Hospital and Research Centre Kuthpady Udupi 
Address  OPD-9 Department of Panchakarma Sri Dharamasthala Manjunatheshwara College Of Ayurveda Hospital and Research Centre Kuthpady Udupi Udupi KARNATAKA 574118 India

Udupi
KARNATAKA
574118
India 
Phone  7594836026  
Fax    
Email  archanaas7406@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manjunath Kanthi 
Designation  BAMS MD(AYU) Assistant Professor Department of Panchakarma 
Affiliation  Sri Dharamasthala Manjunatheshwara College Of Ayurveda Hospital and Research Centre Kuthpady Udupi 
Address  OPD-9 Department of Panchakarma Sri Dharamasthala Manjunatheshwara College Of Ayurveda Hospital and Research Centre Kuthpady Udupi Udupi KARNATAKA 574118 India

Udupi
KARNATAKA
574118
India 
Phone  9844469138  
Fax    
Email  kanthipk03@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Manjunath Kanthi 
Designation  BAMS MD(AYU) Assistant Professor Department of Panchakarma 
Affiliation  Sri Dharamasthala Manjunatheshwara College Of Ayurveda Hospital and Research Centre Kuthpady Udupi 
Address  OPD-9 Department of Panchakarma Sri Dharamasthala Manjunatheshwara College Of Ayurveda Hospital and Research Centre Kuthpady Udupi Udupi KARNATAKA 574118 India

Udupi
KARNATAKA
574118
India 
Phone  9844469138  
Fax    
Email  kanthipk03@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharamasthala Manjunatheshwara Ayurveda Pharmacy Kuthpady Udupi Karnataka India - 574118 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Archana A S  Sri Dharamasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre Kuthpady Udupi  OPD-9 Department of Panchakarma Sri Dharamasthala Manjunatheshwara College Of Ayurveda Hospital and Research Centre Kuthpady Udupi Udupi KARNATAKA
Udupi
KARNATAKA 		 7594836026

archanaas7406@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Dharamsthala Manjunatheshwara College of Ayurveda Udupi Institutional Ethical Clearance Committe-Human  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: VISVACI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-grIvAbastiH, ग्रीवाबस्तिः (Procedure Reference: keraliye panchkarma, Procedure details: the lukewarm oil is poured in the ring made up of black gram dough over the affected area upto 2 inches above the skin level. the temperature of oil is maintained throughout the procedure as per the tolerance of the patient. total duration of the procedure is 30 minutes per day.)
(1) Medicine Name: mahamasha taila, Reference: bhaishajya ratnavali, Route: Topical, Dosage Form: Dravaka, Dose: 150(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients fulfilling diagnostic criteria of cervical spondylosis
2. Patients fit for greeva basti and pratimarsha nasya 
 
ExclusionCriteria 
Details  1. Patients with fracture of cervical spine
2. Patients suffering from neoplastic disorders
3. Patients with major systemic disorders that may interfere with course of treatment
4. Pregnant and lactating women 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary outcome will be assessed based on the
following parameters before and after the
treatment
Subjective parameters
Stiffness
Tingling sensation
Numbness
Pain by visual analogue scale

Objective parameters
Neck disability index
Muscle power 		 0th day, 7th day and 15th day
 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life  0th day & 15th day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   01/01/2025 
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="2"
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   This is an open labelled study evaluating the efficacy of Mahamasha taila greeva basti  with Pratimarsha nasya which will be given for 7 days followed by 8 days of Pratimarsha nasya with mahamasha taila to 30 patients. The study will be conducted in Sri Dharamasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre, Kuthpady, Udupi. The primary outcome measures will be assessed by subjective and objective parameters. The secondary outcome measures will be assessed based on the quality of life scale. Hence this study is an effort to prove the efficacy of Mahamasha Taila Greeva Basti with Pratimarsha Nasya in Viswachi w.s.r to Cervical Spondylosis. 
Close