Ayurvedic management of katigraha( lumbar spondylosis)
- Conditions
- Other spondylosis with radiculopathy. Ayurveda Condition: VATAVYADHIH, (2) ICD-10 Condition: M199||Osteoarthritis, unspecified site. Ayurveda Condition: PRUSHTHA-GRAHAHÂ (KEVALAVATA),
- Registration Number
- CTRI/2022/12/048545
- Lead Sponsor
- Ramraj Singh
- Brief Summary
Afterclearance from Institutional Ethics Committee of Government Ayurved college,Nagpur, Patient visitedto OPD, IPD; Casualty with complaints of low back pain, were recruited from OPD and IPD of GovernmentAyurved College, Nagpur.
During the informed consent process the subjectswere given enough time to read patient information sheet and consent form.(ICF)subjects were alsogiven freedom to ask the questions and all the questions were answered. Ifhe/she agrees for participation in the study and if found fit toinclude during screening then he was recruited in the study. This visit wascalled as screening visit.
On screening visit, after written informedconsent, screening of subject on the basis of clinical assessment for katigrha(i.e. lumbar Spondylosis) and fulfilling the diagnostic criteria . If allinclusion criteria is YES and all exclusion NO then subjects will be includedon the basis of criteria given as Roland Morris low back pain and disabilityquestionnaire and X-Ray Lumbosacral Spine
Subjects were then undergo general and systemic examinations.Clinical symptoms Katigrah was assessed along with VASand WOMAC scale and recorded in the CRF . Study design will be **Parallel Group Randomised Control Trial**
**Parallel studydesign of Groups and Drugs Given in Respective Groups**
.**Table-1**
| | |
| --- | --- |
|**Group Trial**
**Group Control**
|0 Day assessment (Before treatment) on admission day
0 Day assessment (Before treatment) on admission day
|Pachana for 5 days
pachana for 5 days
|Assessment On 6 day
Assessment On 6 day
|Local application of Katibasti followed by Administration of *Panchatikta* *kshira* *Basti* along with oral administration of *Vatari* *Guggulu*. .
Local application of Katibasti followed by Administration of *Panchatikta* *kshira* *Basti* along with oral administration of *Erandmula* *Ghanavati.*
|Assessment On 16 day
Assessment On 16 day
|Assessment after completion of treatment.
Assessment after completion of treatment.
**Durationof *Basti* :** 15 days
**Duration of *Shamana Dravya***: 30 days
**Treatment Regimen:**
**Trial Group**
**Table-2**
| | | | | |
| --- | --- | --- | --- | --- |
|**Treatment given**
**Duration**
**Dose**
***Anupana***
***Bheshaja***
***Sevankala***
|Vatari Guggulu
30 days
500mg BD
Ushnodak
Apankal
|Til tail Katibasti
15days
200 ml
----
Morning hour 9-10 am
|Panchatikta Kshirabasti
15 days
240 ml
----
Paschat bhakta once a day morning time
(11 to 11:30am)
**Control Group**
**Table-3**
| | | | | |
| --- | --- | --- | --- | --- |
|**Treatment given**
**Duration**
**Dose**
***Anupana***
***Bheshaja***
***Sevankala***
|*Erandamula* *Ghanavati*
30 days
500mg BD
Ushnodak
Apankal
|*Til Tail Katibasti*
15days
200 ml
----
Morning hour 9-10 am
|*Panchatikta* *Kshirabasti*
15 days
240 ml
----
Paschat bhakta once a day morning time
(11 to 11:30am)
.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 98
- 1.Patients of either sex aged between 18- 70 years irrespective of caste, religion, socioeconomic & educational status.
- 2.The Roland and Morris disability questionnaire; if RDQ score> 5 3.Radiological degenerative changes in Lumbar spine.
- 4.Patients having sign and symptoms of Katigrah according to classics.
- 5.Patient willing and able to participate in the study.
- 6.Chronic low back pain more than three months.
- 1.History of any fracture of vertebral joint/ surgical/ diagnostic intervention with reference to affected joints will be excluded.
- 2.Gross disability in performing daily normal routine i.e. bedridden patient or confined to a wheelchair will be excluded.
- 3.Patient with co-morbidities such as gouty arthritis, rheumatoid arthritis or psoriatic arthritis and tubercular arthritis.
- 4.Patient with any deformity of hip or back altering the gait and posture of the patient, ankylosing spondylitis, pelvic inflammatory disorders.
- 5.Patient with uncontrolled hypertension and uncontrolled diabetes will be ruled out.
- 6.Patient with evidence of malignancy.
- 7.Patient on prolonged (≥6weeks) medication with corticosteroids, non-steroidal anti-inflammatory drug, antidepressants, anti-cholinergic etc.
- or any drugs that may influence on the outcome of the study.
- 8.Pregnant / lactating women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To Evaluate the synergistic effect of Vatari Guggulu, Panchatikta Kshira Basti along with Kati Basti particularly on the Rolland and Morris disability questionnaire and clinical features of Katigrah with special reference to Lumbar Spondylosis. 35 Days 2.To compare the effect of Vatari Guggulu, Panchatikta Kshira Basti along with Kati Basti with Erandamula Ghanavati , Panchatikta Kshira Basti along with Kati Basti particularly on Rolland Morris Index. 35 Days
- Secondary Outcome Measures
Name Time Method WOMAC Score VAS Score
Trial Locations
- Locations (1)
Government Ayurveda College And Hospital, Nagpur
🇮🇳Nagpur, MAHARASHTRA, India
Government Ayurveda College And Hospital, Nagpur🇮🇳Nagpur, MAHARASHTRA, IndiaRamraj SinghPrincipal investigator7999912473ramrajsingh0625@gmail.com