| CTRI Number |
CTRI/2024/08/072600 [Registered on: 16/08/2024] Trial Registered Prospectively |
| Last Modified On: |
08/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Greeva Basti (Moolak Taila) and Raktamokshan (Wet cupping) In The Management of Manyastambha (Cervical Spondylosis) |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Effficacy Of Greeva Basti (Moolak Taila) With Intermittent Raktmoskhan (Wet Cupping) And Only Greeva Basti (Moolak Taila) In The Management Of Manyastambha W.S.R 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 Megha Agarwal |
| Designation |
MD Scholar |
| Affiliation |
Post Graduate Institute of Ayurved |
| Address |
PG Department of Panchkarma Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Campus Kadvad Jodhpur Rajasthan India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7597278971 |
| Fax |
|
| Email |
megha.agar1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gyan Prakash Sharma |
| Designation |
Associate Professor & HOD |
| Affiliation |
Post Graduate Institute of Ayurved |
| Address |
PG Department of Panchkarma Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Campus Kadvad Jodhpur Rajasthan India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9829798701 |
| Fax |
|
| Email |
atreyagyan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Megha Agarwal |
| Designation |
MD Scholar |
| Affiliation |
Post Graduate Institute of Ayurved |
| Address |
PG Department of Panchkarma Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Campus Kadvad Jodhpur Rajasthan India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7597278971 |
| Fax |
|
| Email |
megha.agar1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University
Jodhpur 342037 Rajasthan INDIA |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurved DSRRAU Jodhpur |
| Address |
PG Department of Panchkarma Post Graduate Institute of Ayurved
DSRRAU Jodhpur 342037 Rajasthan INDIA |
| 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 Megha Agarwal |
Post Graduate Institute of Ayurved DSRRAU Jodhpur |
PG Department of Panchkarma Post Graduate Institute of Ayurved DSRRAU Jodhpur Nagaur Road Kadwad Jodhpur Rajasthan 342037 INDIA
Jodhpur
RAJASTHAN |
7597278971
megha.agar1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Post Graduate Institute of Ayurved |
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 | - | grIvAbastiH, गà¥à¤°à¥€à¤µà¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Yog Ratnakar Chikitsa 25, Procedure details: 20 Patients will be treated with Greeva Basti with Moolak Taila)
(1) Medicine Name: Moolak Taila, Reference: Charak Chikitsa 28, Route: Topical, Dosage Form: Taila, Dose: 350(ml), Frequency: od, Duration: 14 Days | | 2 | Comparator Arm | Procedure | - | raktamokShaNam/ SoNitasrAvaH/ asravisrutiH/ SastravisrAvaNam, रकà¥à¤¤à¤®à¥‹à¤•à¥à¤·à¤£à¤®à¥/ शोणितसà¥à¤°à¤¾à¤µà¤ƒ/ असà¥à¤°à¤µà¤¿à¤¸à¥à¤°à¥à¤¤à¤¿à¤ƒ/शसà¥à¤¤à¥à¤°à | (Procedure Reference: Sushrut Sutra 13, Procedure details: 20 Patients will be treated with Greeva Basti with Moolak Taila & intermittent Raktmokshana)
(1) Medicine Name: Moolak Taila, Reference: Charak Chikitsa 28, Route: Topical, Dosage Form: Taila, Dose: 350(ml), Frequency: od, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed and confirmed cases of Manyastambha (Cervical Spondylosis) as per case report on the basis of sign and symptoms
Patients between the age group of 18 to 65 years of either sex religion and occupation
Patients willing to give written consent
|
|
| ExclusionCriteria |
| Details |
Pregnant and lactating woman
Subjects contraindicated for Greeva basti and Raktmokshana
Stenosis of spinal canal and myelopathy
Patients suffering with other systemic chronic disorders like malignancy and cardiac and renal disease and also diabetic patients
Ankylosing spondylitis adhesive capsulitis fracture and dislocation involving shoulder joint
Patient having HIV and HEPATITIS infection
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To see the effect on subjective and objective parameters |
30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To see any other effects of drug and procedures |
30 Days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/09/2024 |
| 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="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Study Type - Interventional
Number Of Patients- 40(20 Patients in each group)
Type of study- Open Labelled
Duration of study- 30 Days
Follow Up- For Group A :- Total duration of treatment 30 days including 15 days follow up (1st Day Cupping and 1 to 7 Days Greeva Basti then 8th day cupping then 9 to 15 days Greeva Basti and 15th day Cupping For Group B :- Total duration of treatment 28 days including 14 days Greeva Basti and 14 days follow up |