| CTRI Number |
CTRI/2024/03/064019 [Registered on: 12/03/2024] Trial Registered Prospectively |
| Last Modified On: |
23/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To study effect of ayurvedic medicated oil in cervical spondylosis |
|
Scientific Title of Study
|
Study the efficacy of sahachar tail matra basti in the management of manyastambha. |
| 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 Om Dattatray Davhale |
| Designation |
PG scholar |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Dept. Of Panchakarma,
Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurvedic Hospital,
Rasta peth
Pune
MAHARASHTRA
411011
India |
| Phone |
8605505176 |
| Fax |
|
| Email |
Omdavhale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul Surendra Kathawate |
| Designation |
Associate Professor |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Dept. Of Panchakarma,
Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurvedic Hospital,
Rasta peth
Pune
MAHARASHTRA
411011
India |
| Phone |
7385201786 |
| Fax |
|
| Email |
vdrahulkathawate@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahul Surendra Kathawate |
| Designation |
Associate Professor |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Dept. Of Panchakarma,
Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurvedic Hospital,
Rasta peth
MAHARASHTRA
411011
India |
| Phone |
7385201786 |
| Fax |
|
| Email |
vdrahulkathawate@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurvedic Hospital |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurvedic Hospital |
| Address |
Rasta peth, Pune |
| 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 Om Dattatray Davhale |
Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurvedic Hospital |
Dept of Panchakarma opd no 12
Rasta peth
Pune
MAHARASHTRA |
8605505176
Omdavhale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurved Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M478||Other spondylosis. Ayurveda Condition: MANYASTAMBAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Acharya Vidyadhar Shukla and Prof.RaviduttaTripathi, CharakSamhita vol.2, Chaukhamba Sanskrit Pratishthan,Delhi, 2012 ,Siddhi sthana , Adhyay 4 , shlok 53 page no. 701, Procedure details: Administration of 60ml sahachar tail through rectal route for 15 days)
(1) Medicine Name: Sahachar Taila, Reference: Vaidya shodhal vo.1 Gadniraha Dwiteeya khanda Tailadhikar shlok 106 to 114 page no.98, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having complaining of: Ruk, Stambh, Pidanasahatva
Also complaining of numbness and grip weakness
Patients who are basti Indicated as per ayurved text. (Basti arha Patient) |
|
| ExclusionCriteria |
| Details |
Medical history of cardiac disease,pregnancy,hiv
Cervical radiculopathy, mylopathy
Systemic conditions
Rheumatoid Arthritis, cervical and vertebral fracture, Intestinal surgery. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain , stiffness, tenderness |
0, 8, 16 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| VAS scale, Oxford pain chart, tenderness scale, goniometry |
0, 8, 16, 30 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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/03/2024 |
| 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="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
|
1) The modern treatment includes analgesics which gives temporary relief.
2) Many drugs other than ayurveda used to get relief in manyastambha have limited
results, Ayurveda has the best therapy in the form of panchakarma to make the body free from diseases.
3) The contents of Sahachar tail are recommended in treatment of Vata vyadhi and also effective in AsthimajjagataVata.
4)Many drugs other than Ayurveda used to get relief in Manyastambha have related Results |