| CTRI Number |
CTRI/2024/03/064857 [Registered on: 27/03/2024] Trial Registered Prospectively |
| Last Modified On: |
27/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To see the effect of Trilawan Pashugandhadi churna orally and Lakshadi Oil locally in the management of Katigraha w.r.s. Lumbar Spondylosis. |
|
Scientific Title of Study
|
“Randomized open controlled clinical study to evaluate the efficiency of ‘Trilawan
Pashugandhadi Churna’ orally and ‘Lakshadi Tailam’ locally in the management of
Katigraha w.s.r.to Lumber Spondylosis in the age group of 35 to 70 yearsâ€
|
| Trial Acronym |
Yes |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrUddhav Madhukar Gawali |
| Designation |
PG Scholar Kaychikitsa |
| Affiliation |
Dayabhai Mavaji Majithiya Ayurveda Mahavidyalaya Yavatmal |
| Address |
Department Kaychikitsa OPD NO 10 Ground floor Dayabhai Mavaji Majithiya Ayurveda Mahavidyalaya Yavatmal
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
8888040958 |
| Fax |
|
| Email |
uddhavgawali97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subhash Bhikaji Jamdhade |
| Designation |
HOD and Professor Kaychikitsa Department |
| Affiliation |
Dayabhai Mavaji Majithiya Ayurved Mahavidyalaya Yavatmal |
| Address |
Department Kaychikitsa OPD NO 10 Ground floor Dayabhai Mavaji Majithiya Ayurveda Mahavidyalaya Yavatmal
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
9822201196 |
| Fax |
|
| Email |
drsubhashjamdhade@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Subhash Bhikaji Jamdhade |
| Designation |
HOD and Professor Kaychikitsa Department |
| Affiliation |
Dayabhai Mavaji Majithiya Ayurved Mahavidyalaya Yavatmal |
| Address |
Department Kaychikitsa OPD NO 10 Ground floor Dayabhai Mavaji Majithiya Ayurveda Mahavidyalaya Yavatmal
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
9822201196 |
| Fax |
|
| Email |
drsubhashjamdhade@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayabhai Mavaji Majithiya Ayurved Mahavidyalaya Yavatmal
Maharashtra
Pincode 445001 India |
|
|
Primary Sponsor
|
| Name |
Dayabhai Mavaji Majithiya Ayurveda Mahavidyalaya Yavatmal |
| Address |
Department Kaychikitsa OPD NO 10 Ground floor Dayabhai Mavaji Majithiya Ayurveda Mahavidyalaya Yavatmal Maharashtra 445001 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Subhash Bhikaji Jamdhade |
Dayabhai Mavaji Majithiya Ayurveda Mahavidyalaya Yawatmal |
Lakshamanrao Kalspurkar Ayurveda Rugnalay OPD 10 Department of Kaychikitsa Arni Road Shivaji Nagar Yavatmal Maharashtra 445001 India
Yavatmal
MAHARASHTRA |
9822201196
drsubhashjamdhade@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M471||Other spondylosis with myelopathy. Ayurveda Condition: KATIKATARUNA-MARMAVIDDHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Dashmool Churna , Reference: Bhawprakash Samhita , Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -koshnajal ), Additional Information: (2) Medicine Name: , Reference: Bala Tailam, Route: Bhaishjaratnawali , Dosage Form: Churna/ Powder, Dose: 31(5), Frequency: ml, Bhaishajya Kal: bd, Duration: Adhobhakta, anupAna/sahapAna: No, Additional Information: NA | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Trilawan Pashugandhadi churna , Reference: Sahastra yogam , Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -koshnajal ), Additional Information: -(2) Medicine Name: Lakshadi Tailam , Reference: Sharangadhar Samhita , Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Age group 35- 70 years irrespective of caste religion socio-economic and
educational status
2 The Roland and Morris disability questionnaire if RDQ score more than 5
3 Radiological degenerative changes in Lumbar Spine
4 Patient having sign and symptoms of Katigraha according to classics
5 Patient willing and able to participate in the study
6 Chronic low back pain more than three months
|
|
| ExclusionCriteria |
| Details |
1 History of any fracture of vertebral joints and surgical and diagnostic intervention with
reference to affected joints will be excluded
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 tubular arthritis
4 Patient with any deformity of Hip or back altering the gait and posture of the patient,
ankylosing spondylitis, pelvic i inflammatory disorder
5 Severe alcoholic patient.
6 age group below 35 yrs and above 70 yrs
7 Degenerative disc disease may lead to spinal stenosis (narrowing of the spinal canal),
vertebral instability |
|
|
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
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
In present clinical trial the patient will be assessed based on the signs and symptoms
mentioned described in the Ayurveda texts
(A) SUBJECTIVE CRITERIA
The parameters will be noted down before and after treatment
1 Katishul (Lumbar region)
2 Aakunchan Prasaran Shula (Pain on flexion and extension)
3 Graha (Stiffness)
4 Pindanashtava (Tenderness)
5 Anidra |
0 7th 15th 22nd 29th 36th 45th 60th 75th 90th Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
OBJECTIVE CRITERIA
1 Roland & Morris Disability Questionnaire
2 VAS scale |
0 7th 15th 22nd 29th 36th 45th 60th 75th 90th 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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/04/2024 |
| 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 Applicable |
| 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
|
Lumbar Spondylosis may be correlated with Katigraha on the basis of clinical features of the disease. Katigraha as an independent disease entity for the first time was described in Gadnigraha in Vatavyadhi chapter³ with the same description made available in Bhavprakash². Vata Dosha with or without Ama dosha settles in Kati and causes pain and stiffness in the Katipradrsh (Lumbar Spondylosis). |