| CTRI Number |
CTRI/2023/03/050994 [Registered on: 23/03/2023] Trial Registered Prospectively |
| Last Modified On: |
22/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
EVALUATION OF THE EFFECT OF KATI BASTI, MATRA BASTI, ALONG WITH SHAMAN DRUG AND PHYSIOTHERAPY IN THE MANAGEMENT OF KATIGRAHA WITH SPECIAL REFERENCE TO LUMBAR DISC HERNIATION |
|
Scientific Title of Study
|
EVALUATION OF THE EFFECT OF KATI BASTI, MATRA BASTI, ALONG WITH SHAMANA DRUG AND PHYSIOTHERAPY IN THE MANAGEMENT OF KATIGRAHA WITH SPECIAL REFERENCE TO LUMBAR DISC HERNIATION |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shubham Borkar |
| Designation |
MD Scholar |
| Affiliation |
Pt Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Science Hills Bhopal (MP) |
| Address |
PG Department of Panchakarma Pt Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Science Hills Bhopal (MP)
PG Department of Panchakarma Pt Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Science Hills Bhopal (MP)
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8823807687 |
| Fax |
|
| Email |
kalyanam300995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PREETI CHATURVEDI |
| Designation |
READER OF DEPARTMENT OF PANCHKARMA |
| Affiliation |
Pt. KHUSHILAL SHARMA GOVT. (AUTO) AYURVEDA COLLEGE & INSTITUTE BHOPAL |
| Address |
PG Department of Panchakarma Pt Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Science Hills Bhopal (MP)
PG Department of Panchakarma Pt Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Science Hills Bhopal (MP)
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
7999013557 |
| Fax |
|
| Email |
preetichaturvedi227@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PREETI CHATURVEDI |
| Designation |
READER OF DEPARTMENT OF PANCHKARMA |
| Affiliation |
Pt. KHUSHILAL SHARMA GOVT. (AUTO) AYURVEDA COLLEGE & INSTITUTE BHOPAL |
| Address |
PG Department of Panchakarma Pt Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Science Hills Bhopal (MP)
PG Department of Panchakarma Pt Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Science Hills Bhopal (MP)
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
7999013557 |
| Fax |
|
| Email |
preetichaturvedi227@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Bhopal (MP) |
|
|
Primary Sponsor
|
| Name |
Pt Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Bhopal (MP) |
| Address |
PG Department of Panchakarma Pt Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Science Hills Bhopal (MP) |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| DrShubham Borkar |
Pt KHUSHILAL SHARMA GOVT AUTO AYURVEDA COLLEGE AND INSTITUTE BHOPAL |
Pt KHUSHILAL SHARMA GOVT AUTO AYURVEDA college & institute near science hills bhopal madhya pradesh
Bhopal
MADHYA PRADESH |
08823807687
kalyanam300995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) Pt Khushilal Sharma Government Ayurveda Institute Bhopal (MP) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M514||Schmorls nodes. Ayurveda Condition: Katigraha, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Kati Basti,Matra Basti | (Procedure Reference: charak sutra13in sneha indication, Procedure details: 20 patients of this group will be treated with Kati Basti & Matara Basti with Dvipanchmooladi tail upto 16 days Medicine Name-Dvipanchmooladi tail, Reference BhaishajyaRatnavali - Aamvaat Chapter-Verse 29-228, Dosage form- taila,Dose-kati Basti-200 ml approx, for matra Basti -60 ml daily Duration-16 days)
(1) Medicine Name: KUBJVINOD RAS, Reference: Rasendra Sar Sangrah-vatvyadhichikitsa pg.620) , Route: Oral, Dosage Form: Capsules, Dose: 250(mg), Frequency: bd, Duration: 16 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | physiotherapy | traction procedure
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with sign and symptoms of Katigraha and MRI diagnosed case of lumbar disc herniation.
2.Patients fit for Basti Karma.
|
|
| ExclusionCriteria |
| Details |
1.Age below 20 years and above 55 years.
2.Patients contraindicated for Basti Karma.
3.Patients having Spinal tumour, Tuberculosis, Malignant disease of the pelvis, fracture of spine, Congenital or Acquired skeletal deformity.
4.Any traumatic condition of spine leading to paralysis.
5.Recent lumbar surgery or implanted instrumentation or prosthesis.
6.Pregnant and lactating women.
7.Having Chronic pathologies eg. Ankylosing spondylosis, Rheumatoid arthritis, Psoriatic arthritis, Gouty arthritis or any other systemic illness.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected that at the end of the study we would be able to demonstrate the effect of Kati Basti, Matra Basti and kubjvinod ras in the management of katigraha. It is further expected that this study would be able to provide comparative efficacy between the ayurvedic treatment regimen and acclaimed physiotherapy in the management of katigraha (lumbar disc herniation). |
Primary assessment in 16 days & after follow up on 30 th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It is expected that this study would be able to provide comparative efficacy between the ayurvedic treatment regimen and acclaimed physiotherapy in the management of katigraha (lumbar disc herniation). |
12 Months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
26/03/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is expected that at the end of the study we would be able to demonstrate the effect of Kati Basti, Matra Basti and kubjvinod ras in the management of katigraha. It is further expected that this study would be able to provide comparative efficacy between the ayurvedic treatment regimen and acclaimed physiotherapy in the management of katigraha (lumbar disc herniation). |