| CTRI Number |
CTRI/2023/07/054758 [Registered on: 05/07/2023] Trial Registered Prospectively |
| Last Modified On: |
04/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of hot application in Cervical spondylosis using foxtail millet bolus |
|
Scientific Title of Study
|
Effect of Kanguchoornapindasweda in 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 Unaisa N |
| Designation |
P G Scholar, Department of Panchakarma |
| Affiliation |
Government Ayurveda Medical College and Hospital, Pulimoodu junction, Thiruvananthapuram |
| Address |
Government Ayurveda Medical College and Hospital, Pulimoodu junction, Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India |
| Phone |
7593049473 |
| Fax |
|
| Email |
unaisa.nondath60@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Unaisa N |
| Designation |
P G Scholar, Department of Panchakarma |
| Affiliation |
Government Ayurveda Medical College and Hospital, Pulimoodu junction, Thiruvananthapuram |
| Address |
Government Ayurveda Medical College and Hospital, Pulimoodu junction, Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India |
| Phone |
7593049473 |
| Fax |
|
| Email |
unaisa.nondath60@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T K Sujan |
| Designation |
Professor and HOD , Department of Panchakarma |
| Affiliation |
Government Ayurveda Medical College and Hospital, Pulimoodu junction, Thiruvananthapuram, |
| Address |
Government Ayurveda Medical College and Hospital, Pulimoodu junction, Thiruvananthapuram, Kerala 695001
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9447071215 |
| Fax |
|
| Email |
drtksujan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda Medical College and Hospital, Thiruvananthapuram |
|
|
Primary Sponsor
|
| Name |
Government Ayurveda Medical College and Hospital |
| Address |
Unaisa N,PG Scholar, Government Ayurveda Medical College and Hospital, Pulimoodu junction Thiruvananthapuram 695001 |
| 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 |
| Unaisa N |
Government Ayurveda college Panchakarma hospital |
Department of Panchakarma, OP NO:1 Government Ayurveda College Panchakarma Hospital, Poojappura, Thiruvananthapuram 695012 Kerala
Thiruvananthapuram
KERALA |
7593049473
unaisa.nondath60@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee(IEC) Govt Ayurveda College Thiruvananthapuram, Kerala, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M479||Spondylosis, unspecified. Ayurveda Condition: AVABAHUKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | talam, तलमॠ| (Procedure Reference: Chikitsa Manjari, Procedure details: 5gm of Rasnadi choornam applied over the vertex before starting the precedure)
(1) Medicine Name: Rasnadi choorna, Reference: Sahasrayogam, Route: Topical, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | piNDasvedaH, पिणà¥à¤¡à¤¸à¥à¤µà¥‡à¤¦à¤ƒ Pradhan Karma | (Procedure Reference: Yogamrutham, Procedure details: 4 pottalis are prepared each containing 250gms of kanguchoorna. The patient should be seated on the table. The hot pottali should be gently applied over the body (42-45 degree celsius).Just pressing the body with pottali should be done. Both pottalis are used alternatively after reheating to maintain uniform temperature throughout the procedure. Same pottali can be used for three days. It should be done for about 30-35 minutes in the 7 postures
)
(1) Medicine Name: Kanguchoorna, Reference: Astanga Hrdaya, Route: Topical, Dosage Form: Churna/ Powder, Dose: 500(g), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Participants diagnosed as per DASH Questionnaire and Oswestry disability index for neck pain. |
|
| ExclusionCriteria |
| Details |
1) Participants with recent history of cervical spine injury
2)Participants with fibrositis, ankylosing spondylitis, and rheumatoid arthritis
3)Participants who are unfit for swedana karma |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
VAS Scale
Range of movement
DASH Questionnare
Oswestry disability index score |
0th day, 8th day & 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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 3 |
|
Date of First Enrollment (India)
|
15/07/2023 |
| 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
|
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 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 common in young and middle-aged people, due to sedentary habits and increase in over exerting working conditions. There is significant degenerative changes seen in 90% of men older than 50 years and 90% of women older than 60 years. In Ayurveda, cervical spondylosis can be clinically compared to Apabahuka, Viswachi or Greevastambha. Swedana is the treatment of choice for vata, kapha and vatakaphaja diseases. Rooksha sweda is indicated for kaphanubandha condition. Choornapindasweda is one of the main procedure that comes under rookshasweda. Choornapindasweda is believed to have a worthy role in the management of degenerative condition as it improves nourishment to the dhathus by removing the obstruction present in various srotas. Kanguchoornapindasweda mentioned in the vathavyadhi chikitsa of Yogamrutham is indicated in avabahuka. Kangu is bagnasandhanakara, brmhana, guru, rooksha, kaphahara, Considering both the dosa kopa and vitiated dosa sthana, kanguchoornapindasweda is selected. The data will be collected through observation, visual analogue scale, Oswestry disability index for neck pain and Disabilities of arm, shoulder and hand questionnaire and goniometry. After collecting the baseline data, detailed examination will be done using clinical case proforma. Choornapindasweda will be done up to 35 minutes for 7 days.Changes in neck pain, pain in shoulder, range of movements and functional assessment will be analysed before treatment, after treatment on the 8th day and follow up on 15th day after treatment. Data will be statistically analysed and presented. |