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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:M478||Other spondylosis. Ayurveda Condition: GRIVASTAMBAH/GRIVAHUNDANAMÂ (KEVALAVATA), |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Procedure | - | piNDasvedaH, पिणà¥à¤¡à¤¸à¥à¤µà¥‡à¤¦à¤ƒ 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 | 2 | Comparator Arm | Procedure | - | piNDasvedaH, पिणà¥à¤¡à¤¸à¥à¤µà¥‡à¤¦à¤ƒ | (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. |