| CTRI Number |
CTRI/2025/01/079545 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
27/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A randomised clinical study to evaluate the effect of Erandamoola Kshara Basti (medicated enema) in the management of Sciatica |
|
Scientific Title of Study
|
A randomized controlled clinical trial to evaluate the effect of Erandamoola Kshara Basti in the management of Vata-Kaphaja Gridhrasi w.s.r. to Sciatica |
| 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 Bhuvaneshwari V Rathod |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharamasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre Kuthpady Udupi |
| Address |
OPD-9 Department of Panchakarma Sri Dharamasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre Kuthpady Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
8880735566 |
| Fax |
|
| Email |
bhuvaneshwarirathod@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajalaxmi M G |
| Designation |
BAMS MD (AYU) Ph.D Associate professor Department of Panchakarma |
| Affiliation |
Sri Dharamasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre Kuthpady Udupi |
| Address |
OPD-9 Department of Panchakarma Sri Dharamasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre Kuthpady Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9448951673 |
| Fax |
|
| Email |
drrajalaxmisdm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajalaxmi M G |
| Designation |
BAMS MD (AYU) Ph.D Associate professor Department of Panchakarma |
| Affiliation |
Sri Dharamasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre Kuthpady Udupi |
| Address |
OPD-9 Department of Panchakarma Sri Dharamasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre Kuthpady Udupi
KARNATAKA
574118
India |
| Phone |
9448951673 |
| Fax |
|
| Email |
drrajalaxmisdm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharamasthala Manjunatheshwara Ayurveda Pharmacy Kuthpady Udupi Karnakata India - 574118 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 Bhuvaneshwari V Rathod |
Sri Dharamasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre Kuthpady Udupi |
OPD-9 Department of Panchakarma Sri Dharamasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre Kuthpady Udupi
Udupi
KARNATAKA |
8880735566
bhuvaneshwarirathod@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OPD-9 Department of Panchakarma Sri Dharamasthala Manjunatheshwara College of Ayurveda Udupi Institutional Ethical Clearance Committee-Human |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M543||Sciatica. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Charaka Samhita, Procedure details: Patient will be made to lie down in a left lateral position with right lower limb flexed at the knee joint with extended left lower limb. The left hand is folded and used as a pillow under the head and Drug will be adminisered.)
(1) Medicine Name: Erandamoola Kshara Basti, Reference: Astang Hrudaya, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 550(ml), Frequency: od, Duration: 3 Days(2) Medicine Name: Mahanarayana Taila, Reference: Bhaishajaya Ratnavali, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 70(ml), Frequency: od, Duration: 5 Days | | 2 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Charaka Samhita, Procedure details: Patient will be made to lie down in a left lateral position with right lower limb flexed at the knee joint with extended left lower limb. The left hand is folded and used as a pillow under the head and Drug will be adminisered.)
(1) Medicine Name: Vaitarana Basti, Reference: Charak Samhita, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 316(ml), Frequency: od, Duration: 3 Days(2) Medicine Name: Mahanarayana Taila, Reference: Bhaishjaya Ratnavali, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 40(ml), Frequency: od, Duration: 5 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects fulfilling the diagnostic criteria
subject fit for basti karma |
|
| ExclusionCriteria |
| Details |
Subjects with any systemic diseases which may interfere with the course of treatment will be excluded |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome will be assessed based on the following parameters
subjective parameters
Pain
Pricking pain
Stiffness
Drowsiness
Loss of appetite
Heaviness
Objective parameters
Straight Leg Raising test
Lassegue Test
Bragard Test
|
0th day, 8th day and 16th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life |
0th & 24th 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
|
N/A |
|
Date of First Enrollment (India)
|
20/02/2025 |
| 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="2"
Months="0"
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
|
A randomised clinical study to evaluate the effect of Erandamoola Kshara Basti in the management of Vata-Kaphaja Gridhrasi w.s.r. to Sciatica. In this study, total 30 patients will be taken in two groups. In Group-A, Erandamoola Kshara Basti is given to 15 patients by making patient to lie down in a left lateral position with right lower limb flexed at the knee joint with extended left lower limb. The left hand is folded and used as a pillow under the head and Drug will be administered. In Group- B, Vaitarana Basti is given to 15 patients by making patient to lie down in a left lateral position with right lower limb flexed at the knee joint with extended left lower limb. The left hand is folded and used as a pillow under the head and Drug will be administered. The study will be conducted at Sri Dharamasthala Manjunatheshwara College of ayurveda, hospital and research centre, Kuthpady Udupi. The primary outcome measures will be assessed by subjective and objective parameters. The secondary outcome measures will be assessed based on quality of life scale. Hence this study is an effort to prove the the efficacy of Erandamoola Kshara Basti in the management of Vata-Kaphaja Gridhrasi w.s.r. to Sciatica. |