| CTRI Number |
CTRI/2025/02/080260 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
31/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
A study on Dasamooladi decoction enema in reducing sudden onset low back pain |
|
Scientific Title of Study
|
The Effect Of Dasamooladi Niruha Vasti In The Management Of Acute Pain In Lumbar 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 |
Anjitha Madhu |
| Designation |
PG Scholar, Department of Panchakarma |
| Affiliation |
Government Ayurveda College Tripunithura |
| Address |
Second year PG Scholar,
Department of Panchakarma
Government Ayurveda College
Dhanwanthari Nagar
Puthiyakavu
Tripunithura
Ernakulam
Government Ayurveda College
Dhanwanthari Nagar
Puthiyakavu
Tripunithura
Ernakulam
Ernakulam
KERALA
682301
India |
| Phone |
9746405200 |
| Fax |
|
| Email |
dranjitharahul@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seena S |
| Designation |
Professor and HOD |
| Affiliation |
Government Ayurveda College, Tripunithura |
| Address |
Dr Seena S
Professor and HOD
Department of Panchakarma
Government Ayurveda College
Tripunithura
Ernakulam
Government Ayurveda College
Dhanwanthari Nagar
Puthiyakavu
Tripunithura
Ernakulam
Ernakulam
KERALA
682301
India |
| Phone |
9447190133 |
| Fax |
|
| Email |
seenas279@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seena S |
| Designation |
Professor and HOD |
| Affiliation |
Government Ayurveda College, Tripunithura |
| Address |
Dr Seena S
Professor and HOD
Department of Panchakarma
Government Ayurveda College
Tripunithura
Ernakulam
Government Ayurveda College
Dhanwanthari Nagar
Puthiyakavu
Tripunithura
Ernakulam
Ernakulam
KERALA
682301
India |
| Phone |
9447190133 |
| Fax |
|
| Email |
seenas279@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College and Hospital Tripunithura
Ernakulam
Kerala-682301
India |
|
|
Primary Sponsor
|
| Name |
Government Ayurveda College, Tripunithura |
| Address |
Government Ayurveda College, Dhanwanthari Nagar
Puthiyakavu
Tripunithura
Ernakulam,Kerala
PIN - 682301 |
| Type of Sponsor |
Other [Government Ayurveda College Tripunithura, Ernakulam] |
|
|
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 Seena S |
Government Ayurveda College and Hospital,Puthiyakavu,Tripunithura, Ernakulam |
Department of Panchakarma
Government Ayurveda College and Hospital
Dhanwanthari Nagar
Puthiyakavu
Tripunithura
PIN 682301, Ernakulam, Kerala, India
Ernakulam
KERALA |
9447190133
seenas279@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Committee for Ethics in Research, Government Ayurveda College, Tripunithura, Kochi, Kerala, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M472||Other spondylosis with radiculopathy. Ayurveda Condition: VATAVYADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Nirooha Vasti | (Procedure Reference: Vangasena Samhitha, Procedure details: Dasamooladi nirooha vasti has to be done continuously for three days.
Mixing of vasti dravya- saindhava(12g),Brihat saindhavadi taila(48ml),Vachadi kalka(12g),Dasamoola kashaya(120ml),Gomutra arka(120ml), Dhanyamla(96ml) are added and mixed together one after the other in successive order, for the first day.
Saindhava(6g),Brihat saindhavadi taila(24ml),Vachadi kalka(6g),Dasamoola kashaya(60ml),Gomutra arka(60ml),Dhanyamla(48ml) are to be mixed in successive order in a khalwa for the next two days.
Purvakarma- Abhyanga with Chinchadi taila and Swedana
Pradhana karma - Administration of vasti dravya through anal route in the direction parallel and straight towards vertebral column after positioning the patient in left lateral position.
After inserting the Vasti netra, the medicine is gently pushed into the rectum with moderate force, allowing a little quantity of medicine to remain in the putaka. Then the patient should lie in supine position till the urge for defaecation occurs. After attending the urge for defecation, patient should take lukewarm water bath and should take cooked rice with green gram soup immediately and take rest. )
|
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Participants aged between 40-70 years. 2)Participants with lumbar spondylosis having pain less than 3 months as per diagnostic criteria.
3) Participants fit for Niruha Vasti.
4) Participants who have given written consent for study. |
|
| ExclusionCriteria |
| Details |
1)Participants with structural deformities related to spine and hip.
2)Participants with fracture or dislocation of vertebrae and ankylosing spondylitis.
3)Participants with bladder or bowel dysfunction and saddle anaesthesia.
4)Participants with congenital anomalies and malignancies.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain intensity assessed by Visual Analogue Scale. |
Assessment done on 0th day, 4th day and 7th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Changes in tenderness assessed by tenderness grading and range of movements of lumbar spine assessed by goniometer
2. Changes in symptoms assessed by Oswestry Disability Index |
Assessment on 0th, 4th and 7th day |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
27/02/2025 |
| 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 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
|
This trial will be conducted to assess the effect of Dasamooladi Niruha Vasti in the management of Acute Pain in Lumbar Spondylosis. The study will be conducted in Participants with acute pain in low back for 3 days, within the age limit 40-70 years, attending IPD of Panchakarma department Government Ayurveda College, Tripunithura, satisfying the inclusion and exclusion criteria. The Primary Outcome is reduction in VAS Score and secondary outcomes are changes in tenderness assessment, and changes in Oswestry Disability Index. Assessment will be done on 0th, 4th and 7th days of trial. |