FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/05/052993 [Registered on: 22/05/2023] Trial Registered Prospectively
Last Modified On: 19/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the effectiveness of Karpasasthyadi Pinda Sweda in cervical spondylosis using dipping and steaming method with dhanyamla  
Scientific Title of Study   A randomized comparative clinical trial on the effect of Karpasasthyadi Pinda Sweda with two different methods of application 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  Dr Shitha Thomas 
Designation  Assistant Professor 
Affiliation  Government Ayurveda College Tripunithura 
Address  Department of Panchakarma Government Ayurveda College Tripunithura Ernakulam Dist Kerala

Ernakulam
KERALA
682301
India 
Phone  9061246383  
Fax    
Email  drshitha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shitha Thomas 
Designation  Assistant Professor 
Affiliation  Government Ayurveda College Tripunithura 
Address  Department of Panchakarma Government Ayurveda College Tripunithura Ernakulam Dist Kerala

Ernakulam
KERALA
682301
India 
Phone  9061246383  
Fax    
Email  drshitha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Athira Panicker 
Designation  PG Scholar 
Affiliation  Government Ayurveda College Tripunithura 
Address  Department of Panchakarma Government Ayurveda College Tripunithura Ernakulam Dist Kerala

Ernakulam
KERALA
682301
India 
Phone  9945127846  
Fax    
Email  menonathirab@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda College, Tripunithura Ernakulam Dist. Kerala 
 
Primary Sponsor  
Name  Government Ayurveda College Tripunithura Ernakulam Dist Kerala 
Address  PG Scholar Department of Panchakarma, Government Ayurveda College, Tripunithura Ernakulam Dist. Kerala 
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 Shitha Thomas  Government Ayurveda College Hospital,Tripunithura  IPD Department of Panchakarma
Ernakulam
KERALA 
9061246383

drshitha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL COMMITTEE FOR ETHICS IN RESEARCH  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
1Intervention ArmProcedure-piNDasvedaH, पिण्डस्वेदः Pradhan Karma(Procedure Reference: Bhaishajya Ratnavali, Procedure details: Warm 4 churna pottali by dipping in heated dhanyamlam. Take two pottalis and check the temperature by touching over the dorsum of the hand. Massage with pottali over body starting from neck to hands, trunk, legs. Replace the cold pottali with warm ones.Repeat the procedure for 7 days with a duration of 45 minutes.)
(1) Medicine Name: Karpasasthyadi pinda sweda , Reference: Bhaishajya Ratnavali, Route: Topical, Dosage Form: Churna/ Powder, Dose: 250(g), Frequency: od, Duration: 7 Days
2Comparator ArmProcedure-piNDasvedaH, पिण्डस्वेदः (Procedure Reference: Bhaishajya Ratnavali, Procedure details: Dhanyamlam is heated in a vessel and mouth of the vessel should be covered with a cloth. When steam appears, pottali is heated by keeping them over the cloth. The hot pottali should be gently applied over the body after confirming the temperature by applying pottalis on dorsum of hand (42-45 degrees). Both pottalis are used alternatively after reheating to maintain a uniform temperature throughout the procedure. It is done in all the 7 body positions (sitting position, supine position, left late)
(1) Medicine Name: Karpasasthyadi churna , Reference: Bhaishajya Ratnavali, Route: Topical, Dosage Form: Churna/ Powder, Dose: 250(g), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Diagnosed case of Cervical Spondylosis satisfying following criteria
Pain on neck region
Limited range of movements flexion extension lateral flexion rotation
With or without radiological changes in x ray suggestive of cervical spondylosis
Duration less than one year
Patients who give consent for participation for study
Patients satisfying the criteria as per Oswestry neck pain index
Patient fit for sweda
 
 
ExclusionCriteria 
Details  Post surgical
Known cases of Fracture
Diagnosed case of Stroke, Autoimmune diseases Malignancy Cardiac disease Parkinsons disease Uncontrolled diabetes
Pregnancy and lactating women 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Oswestry neck pain disability index for following variables – pain intensity, personal care, lifting, reading, headaches, concentration, sleeping work, driving and recreation.
Range of motion using goniometer
 
0th and 8th day assessment
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Assessment of Samyak Rookshana Lakshana using the Samyak Rookshana Lakshana questionnaire  8th Day Assessment 
 
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   Phase 2 
Date of First Enrollment (India)   01/06/2023 
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    
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 common degenerative condition of the cervical spine. It is a condition involving changes to the bones, discs and joints of the neck. These changes are caused by the normal wear-and-tear of ageing. It is one of the common causes of neck pain. With age, the discs of the cervical spine gradually break down, lose fluid, and become stiffer. Cervical spondylosis usually occurs in middle-aged and elderly people. The disease is usually progressive in nature and first intervention is to educate the patient about the natural course of the disease. In conventional medicine, analgesics, anti-inflammatories and muscle relaxants are used depending on the intensity of the pain.                                                                                                 

In Ayurveda, Cervical spondylosis can be compared to Greevasthambham. It is a vataja nanatmaja vikara mentioned by Acharya Charaka. Karpasasthyadi Pinda sweda is mentioned in Bhaishajya Ratnavali, sula rogadhikara for the management of pain over siras, skanda and kati. The drugs mentioned in this yoga have vatakaphahara action. Sweda is a procedure alleviating both vata and kapha doshas. It is mentioned in classics that, when there is vitiation of sthanika and aganthu dosha, we have to do the management of Sthanika dosha first when it is stronger than Aganthu dosha. In Greevasthambham, sthanika dosha is kapha and aganthu dosha is vata. So rooksha sweda may be beneficial at the initial stage when there is dominance of kapha dosha. The objective of the study is to evaluate the effect of karpsasthyadi pinda sweda in cervical spondylosis by administering it in two different methods i.e., dipping the pottali in heated dhanyamlam and steaming the pottali in dhanyamlam. The study is comparative with pre and post-test. Consequtive cases irrespective of gender, aged 25 to 65 years, attending the IP Department of Govt. Ayurveda College Hospital, Tripunithura satisfying the inclusion criteria and exclusion criteria till the attainment of sample size. Assessment should be done on 0th day and 8th day based on the criteria. Results will be statistically analysed.

 
Close