| CTRI Number |
CTRI/2024/09/074391 [Registered on: 25/09/2024] Trial Registered Prospectively |
| Last Modified On: |
25/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Screening |
| Study Design |
Other |
|
Public Title of Study
|
TO STUDY THE EFFECT OF NARAYAN TAILAM GRIVABASTI WITH ERAND BHRUSHTA HARITAKI CHURNA AND ARKA PATRA PINDA SWED WITH ERAND BHRUSHTA HARITAKI CHURNA IN THE MANAGEMENT OF ASTHIGATA VATA WITH SPECIAL REFERENCE TO CERVICAL SPONDYLOSIS |
|
Scientific Title of Study
|
COMPARATIVE CLINICAL STUDY TO ACCESS THE EFFECT OF NARAYAN TAILAM GRIVABASTI WITH ERAND BHRUSHTA HARITAKI CHURNA AND ARKA PATRA PINDA SWED WITH ERAND BHRUSHTA HARITAKI CHURNA IN THE MANAGEMENT OF ASTHIGATA VATA WITH SPECIAL REFERENCE 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 Bhagyashri Rajdhar Mali |
| Designation |
MD Scholar Panchakarma (Ayurveda) |
| Affiliation |
LRP Ayurvedic Medical College and Hospital |
| Address |
Department of Panchakarma Unit 1 LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Islampur Sangli,Maharashtra
Sangli
MAHARASHTRA
415409
India |
| Phone |
7057045241 |
| Fax |
|
| Email |
bhagyashrimali0096@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Kumar Parida |
| Designation |
HOD |
| Affiliation |
LRP Ayurvedic Medical College and Hospital |
| Address |
Department of Panchakarma Unit 1 LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Islampur Sangli,Maharashtra
Sangli
MAHARASHTRA
415409
India |
| Phone |
8830333050 |
| Fax |
|
| Email |
dpkparida@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Kumar Parida |
| Designation |
HOD |
| Affiliation |
LRP Ayurvedic Medical College and Hospital, Islampur |
| Address |
Department of Panchakarma Unit 1 LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Islampur Sangli,Maharashtra
Sangli
MAHARASHTRA
415409
India |
| Phone |
8830333050 |
| Fax |
|
| Email |
dpkparida@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Islampur Sangli-415409,Maharashtra,India |
|
|
Primary Sponsor
|
| Name |
LRP Ayurvedic Hospital and Research Centre |
| Address |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Islampur Sangli-415409,Maharashtra,India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Bhagyashri Rajdhar Mali |
LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre, Islampur |
Department of Panchakarma,Unit 1,Room no 1,LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centre Islampur Sangli-415409
Sangli
MAHARASHTRA |
7057045241
bhagyashrimali0096@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Report of Ethics Committee, LRP college and Research Institute, Islampur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M478||Other spondylosis. Ayurveda Condition: ASTHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | grIvAbastiH, गà¥à¤°à¥€à¤µà¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Sushrut Samhita, Procedure details: Purvakarma
1.Preparation of patient. The patient undergoing grivabasti will be made to lie on prone
position on the abhyanga table (Droni)
2. Preparation of rim with help of basti yantra (mould) and wheat flour dough
Using dough it will be fixed firmly on neck region where the highest pain is
present
Pradhankarma
1. Warm Narayan tailam will be poured on the inner wall of rim up to an extent
that level stands up to 2 inch above the skin level
2. It will be allowed to remain there for 20 minutes. Tailam will be replaced
with warm tailam in between using syring to maintain the uniform temperature
throughout the procedure
Paschatkarma
1. At the end of the procedure the tailam and dough, basti yantra will be removed.
2. Area will be cleaned by wiping with a clean dry cotton towel.
3. A gentle massage will be given over the area and the person will be ask to take rest for
15 minutes)
(1) Medicine Name: Erand Bhrushta Haritaki Churna, Reference: Bhavprakash Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | | (Procedure Reference: , Procedure details: )
|
|
|
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient fulfilling classical Lakshanas of asthigata vata
(asthishul, mansabalkshay, aswapna, santatruk)
2.Patient without any systemic disorder
3.Those who are fit for grivabasti and swedan karma
4.Patient will be selected irrespective of gender
5.Age group 30-60 |
|
| ExclusionCriteria |
| Details |
1.Age below 30 years and above 60 years
2.Those who are not fit for grivabasti and swedan karma
3.Chronic alcoholic and smoker
4.Patients with cardiac problems and any other fatal disease
5.Patients with multi system diseases or who are seriously ill
6.Patients of frozen shoulder, migraine, emaciated disease, neurological disease
7.Pregnant women
8.Patient with chronicity more than 2 years |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Narayan tailam grivabasti and Erand bhrushta haritaki churna and Arka patra pinda swed and Erand bhrushta haritaki churna in management of Asthigata vata with reference to cervical spondylosis |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To reduce the Asthigata vata in 30 days
To study the literature related to concept of Asthigata vata
To study the concept of Grivabasti and Patra pinda swed
To study the concept of Erand bhrushta haritaki churna |
30 days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
10/10/2024 |
| 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="2" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
At current situation cervical spondylosis is commonly occuring disorder due to change in lifestyle that is sterss factor, day sleep, travelling, improper posture of sitting and sleeping. Ashtigata vata is vyadhi in which vata dosha is localized in manyasthan. It shows lakshana as santat ruk (pain), balkshay (weakness), aswapna (insomnia), stambha (stiffness), sotha (swelling). Asthigata vata keeps resembelance with cervical spondylosis in modern perspective. Cervical spondylosis is chronic degenerative condition of cervical spine that affects the vertebral bodies and intervertebral disc of neck as well as contents of spinal cord. It is common among the elderly person above 30 years.About 90% male aged above 50 years and 90% of female aged above 60 years shows degenerative changes leading to cervical spondylosis. The evidance of degeneration is mostly found at C5-C6 vertebra even followed by C6-C7 and C4-C5 vertebra. For Vatavyadhi mainly snehan,swedan and mrudu shodhan chikitsa are mentioned. Here snigdha snehan with Narayan tail grivabasti has balya,dhatu pushtikar gunas that will give strength to surrounding tissue.And arka patra pinda has vedanahar, shothohar effect that will cause vasodilation, helps to increase the blood ciculation in that region and mrudu shodhan with erand bhrushta haritaki churna will be used for vata dosha shaman.
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