| CTRI Number |
CTRI/2024/11/076667 [Registered on: 12/11/2024] Trial Registered Prospectively |
| Last Modified On: |
29/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study and Compare the effect of Devdarubaladi oil and til oil in patients of lumber spondylosis on administration through anal route. |
|
Scientific Title of Study
|
A comparative clinical study of efficacy of Devdarubaladi taila and Tila taila Matra basti in Katisandhigata vata with special reference to Lumbar spondylosis |
| 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 Vishal Sanjay Aghao |
| Designation |
Post Graduate resident |
| Affiliation |
APMs Ayurved Mahavidyalaya sion Mumbai |
| Address |
Department of Panchakarna, 2nd floor APMs Ayurved Mahavidyalaya sion near sion railway station Mumbai
400022
Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
7507781667 |
| Fax |
|
| Email |
vishalaghao1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajendra Govind More |
| Designation |
HOD and Associate Professor |
| Affiliation |
APMs Ayurved Mahavidyalaya sion Mumbai |
| Address |
Department of Panchakarma 2nd floor, APMs Ayurved Mahavidyalaya sion
near sion railway station Mumbai 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9967520554 |
| Fax |
|
| Email |
rmrushi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajendra Govind More |
| Designation |
HOD and Associate Professor |
| Affiliation |
APMs Ayurved Mahavidyalaya sion Mumbai |
| Address |
Department of Panchakarma 2nd floor, APMs Ayurved Mahavidyalaya sion
near sion railway station Mumbai 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9967520554 |
| Fax |
|
| Email |
rmrushi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurvidya Prasarak Mandal |
|
|
Primary Sponsor
|
| Name |
Dr.Vishal Sanjay Aghao |
| Address |
APMs Ayurved Mahavidyalaya sion, near sion railway station, mumbai 400022 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrVishal Sanjay Aghao |
Seth R V Ayurvedic hospital |
Department of Panchakarma, OPD no 1 near sion railway station , sion, mumbai
Mumbai
MAHARASHTRA |
7507781667
vishalaghao1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| APMs Ayurved Mahavidyalaya sion IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M479||Spondylosis, unspecified. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Charak Siddhistan Adhyay 3 shlok no 28., Procedure details: Purva karma (pre- operative)
1 Patients vital will be taken.
2 Sthanik snehan with tila oil and sthanik swedana of nitamb,prushta,kati , will be done.
3 Patient will be made to lie in left lateral position.
4 Warm Devdarubaladi oil of 60 ml will be added in the basti putak (syringe).
5 Lubrication of catheter will be done.
Pradhan karma (operative)
1 lubricated catheter will be inserted upto the 4.5cm into the anal canal parallel to spine.
2 By gently pushing the oil by applying uniform pressure , patient will be asked to take slow deep breath.
3 catheter will be removed slowly.
Paschat karma (Post operative)
1 pat/massaging of the buttocks will be done.
2 Patient will be asked to sleep in supine position for 10min)
(1) Medicine Name: Devadarubaladi oil, Reference: Devdarubaladi Taila: Sahasrayoga, Tailaprakaran page no. 260., Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 14 Days | | 2 | Comparator Arm | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Charak Siddhistan Adhyay 3 shlok no 28, Procedure details: Purva karma (pre- operative)
1 Patients vital will be taken.
2 Sthanik snehan with tila oil and sthanik swedana of nitamb,prushta,kati , will be done.
3 Patient will be made to lie in left lateral position.
4 Warm tila oil of 60 ml will be added in the basti putak (syringe).
5 Lubrication of catheter will be done.
Pradhan karma (operative)
1 lubricated catheter will be inserted upto the 4.5cm into the anal region parallel to spine.
2 by gently pushing the oil by applying uniform pressure , patient will be asked to take slow deep breath.
3 catheter will be removed slowly.
Paschat karma (Post operative)
pat/massaging of the buttocks will be done.
Patient will be asked to sleep in supine position for 10min.)
(1) Medicine Name: Tila oil , Reference: Chunekar KC. Bhavprakash Nighantu. Varanasi: Chaukhamba Publication; 2010. Pg 639., Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 14 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient having classical sign and symptoms of Katisandhigat Vata and Patient who are willing to
participate in the study
Katishoola (pain in low back)
Katistambha (stiffness of lower back)
Akunchana Prasarana Pravrutti Savedana (painful joint movements)
Both male and female included of age 20yrs to 60yrs
Radiological evidence of Lumbar spondylosis confirmed by X-ray |
|
| ExclusionCriteria |
| Details |
Patient with congenital or acquired abnormality related to joint will be excluded
Patients suffering from carcinoma, TB, AIDS,CKD and immune compromised will be excluded
Patient suffering from RA, GOUT, or other inflammatory major joint diseases.
Patient associate with simple or compound fracture associated with trauma
Pregnant women, lactating mother and during menstrual cycle.
Patients is not willing
Patients undergoing steroid therapy |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Universal pain assessment tool grading 0 to 10
Xray LS Spine
|
14 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Katishoola (pain in low back)
Katistambha (stiffness of lower back)
Akunchana Prasarana Pravrutti Savedana (painful joint movements). |
14 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 4 |
|
Date of First Enrollment (India)
|
17/11/2024 |
| 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 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
|
Lumbar Spondylosis is one of the major cause for reduction of millions of work Hours daily and annually. The current management includes NSAID’S, local anaesthesia, Steroids, sedatives etc, gives temporary relief from pain but has got severe adverse effects. In Spite of recent advances in western science, the treatment is mere-symptomatic, but symptomatic management of any disease is incomplete as it cannot break up the chain of Pathogenesis. So need arises to search for a safer, better and cheaper treatment,thus Improving functional ability in this group of patients is important .It has become clear that the way of treatment prevailing until Recently,was insufficient to to give a better life for patients. Panchakarma is a unique Approach of Ayurveda which is specially designed for internal purification of body via nearest possible route.The vitiated factors settled in target organs (marma asthisandhis) have to be bought back to koshta and eliminated from there by sodhana line of treatment. To overcome this problem devdarubaladi taila matra basti will be given to the patient having katisandhighat vata |