| CTRI Number |
CTRI/2021/09/036592 [Registered on: 17/09/2021] Trial Registered Prospectively |
| Last Modified On: |
16/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
LUMBAR SPONDYLOSIS AND ITS MANAGEMENT THROUGH AYURVEDA
|
|
Scientific Title of Study
|
CLINICAL STUDY TO EVALUATE THE EFFICACY OF MATRA BASTI AND KATI BASTI WITH NIRGUNDI TAILA IN THE MANAGEMENT OF KATIGRAHA (LUMBAR SPONDYLOSIS) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sarita devi |
| Designation |
MD SCHOLAR |
| Affiliation |
DSRRAU JODHPUR |
| Address |
P.G. Department of Panchakarma , University College of Ayurveda ,
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University , Karwar
, Nagaur Road , Jodhpur
P.G. Department of Panchakarma , University College of Ayurveda ,
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University , Karwar
, Nagaur Road , Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9649991813 |
| Fax |
|
| Email |
drsaritachoudhary1992@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gyan Prakash Sharma |
| Designation |
Assocciate Professor |
| Affiliation |
DSRRAU JODHPUR |
| Address |
P.G. Department of Panchakarma , University College of Ayurveda ,
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University , Karwar
, Nagaur Road , Jodhpur
P.G. Department of Panchakarma , University College of Ayurveda ,
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University , Karwar
, Nagaur Road , Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9829798701 |
| Fax |
|
| Email |
atreyagyan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarita devi |
| Designation |
MD Scholar |
| Affiliation |
DSRRAU, Jodhpur |
| Address |
P.G. Department of Panchakarma , University College of Ayurveda ,
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University , Karwar
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University ,Karwar,
Nagaur Road ,Jodhpur , PIN 342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9649991813 |
| Fax |
|
| Email |
drsaritachoudhary1992@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University , Jodhpur |
|
|
Primary Sponsor
|
| Name |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
| Address |
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University ,Karwar,
Nagaur Road ,Jodhpur , PIN 342037 |
| 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 Gyan Prakash Sharma |
Dr. Sarvepaali Radhakrishanan Rajasthan Ayurved University, University Hospital of Ayurveda |
OPD No- 6 , P.G
DEPARTMENT OF
PANCHAKARMA ,Dr.
Sarvepalli
Radhakrishnan
Rajasthan Ayurved
University , Karwar,
Nagaur Road ,Jodhpur ,
PIN 342307
Jodhpur
RAJASTHAN
Jodhpur
RAJASTHAN |
9829798701
atreyagyan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee DSRRAU Jodhpur |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M478||Other spondylosis. Ayurveda Condition: KATIGRAHA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Chakra datta Vatavyadi Chikitsa1, Procedure details: Group A Matra basti with nirgundi taila 60 ml for 14 days.
Group B Kati basti with Nirgundi taila for 14 days.)
(1) Medicine Name: Nirgundi tail, Reference: Charaka Chikitsa, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 14 Days |
|
|
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Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients diagnosed as katigharah.
2.Patient yogya for Basti Karma.
|
|
| ExclusionCriteria |
| Details |
1.Patients suffering from Potts spine.
2.Patients suffering from Lumber canal stenosis.
3.Patients suffering from Metastatic disease of spine.
4.Patients suffering from Diabetic neuropathy.
5.Patients suffering from Scoliosis, kyphosis.
6.Patients suffering from Uncontrolled hypertension and history of HIV.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in subjective and objective
parameters |
45day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find out the comparative efficacy of the
treatment in both the groups |
45 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/09/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Spondylosis is very common disease (more than 1 crore cases per year in india)It is a form of lower back pain and is an important clinical, socio-economic and public health problem affecting the world-wide population.Low back pain affects approximately60%-80% of adults and LS is responsible for about 10%of all the back pain conditions. Vatavyadhis coms under a group of disease which manifest by dhatukshaya or margavaran and those are classified according to hetu, sthan and lakshana. In the classification of dhatukshayajanyavatavyadhis ,many degenerative conditions are considered.In present scenario, the treatment modalities for lumbar spondylosis is conservative treatment with analgesic, physiotherapy,muscle relaxants , narcotics and few require surgery which has its own disadvantages or expensive. Various internal and external medications and procedures for this disease are available in Ayurveda The alkaloid nishidine ,present in root of nirgundi .Nirgundi is also reduce swelling and analgesic and anti inflammatory. Basti is mentioned as the line of treatment of vatavyadhis by Acharyas of Ayurved |