| CTRI Number |
CTRI/2024/05/067133 [Registered on: 10/05/2024] Trial Registered Prospectively |
| Last Modified On: |
02/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study to see the effect of devdarubaladi taila matra basti( medicated oil enema) in the management of katigata vata(low back pain) |
|
Scientific Title of Study
|
A Single Arm Clinical Study to evaluate the efficacy of Devdarubaladi Taila Matra Basti in the management of Katigata Vata(Low Back Pain) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Sayli Subhash Anbhavane |
| Designation |
MD PG scholar Pachakarma |
| Affiliation |
Dr. D.Y.Patil College of Ayurveda and Research Centre, Pimpri, Pune |
| Address |
Panchakarma Department OPD No. 9 Dr.D.Y.Patil College of Ayurveda and Research Centre, Sant Tukaram Nagar,Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7798204305 |
| Fax |
|
| Email |
om.sayli@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pranesh P Gaikwad |
| Designation |
M.D. Panchakarma (Associate Professor) |
| Affiliation |
Dr. D.Y.Patil College of Ayurveda and Research Centre, Pimpri, Pune |
| Address |
Dr.D.Y.Patil College of Ayurveda and Research Centre, Sant Tukaram Nagar,Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8668259365 |
| Fax |
|
| Email |
pranesh.gaikwad@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Vd Sayli Subhash Anbhavane |
| Designation |
MD PG scholar Panchakarma |
| Affiliation |
Dr. D.Y.Patil College of Ayurveda and Research Centre, Pimpri, Pune |
| Address |
Panchakarma Department OPD No. 9 Dr.D.Y.Patil College of Ayurveda and Research Centre, Sant Tukaram Nagar,Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7798204305 |
| Fax |
|
| Email |
om.sayli@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D.Y.Patil College of Ayurveda and Research Centre, Pimpri |
|
|
Primary Sponsor
|
| Name |
Vd Sayli Subhash Anbhavane |
| Address |
Dr.D.Y.Patil College of Ayurveda and Research Centre, Sant Tukaram Nagar,Pimpri, Pune, Maharashtra 411018 |
| 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 |
| Vd Sayli Subhash Anbhavane |
Dr.D.Y.Patil College of Ayurveda and Research Centre, Pimpri,Pune |
Panchakarma department,OPD No 9,Dr.D.Y.Patil College of Ayurveda and Research Centre, Pimpri,Pune,Maharashtra-411018
Pune
MAHARASHTRA |
7798204305
om.sayli@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR.DYPCA & RC INSTITUTIONAL ETHICS COMMITTEE, PIMPRI, PUNE-18 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M489||Spondylopathy, unspecified. Ayurveda Condition: VATAVYADHIH, |
|
|
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 Samhita, Procedure details: (Procedure Reference: Charak Samhita, Procedure details: Collection of drugs & oils for snehana and swedana ask patient to have light lunch prior to matra basti karma.Sthanik snehana and swedana karma at kati spika and udara regions ask patient to lie in left lateral position with left leg straight and right leg flexed.Glycerine syringe will be tied to rubber catheter and Devdarubaladi Taila will be loaded in the syringe(100 CC),air will be removed and rubber catheter will be administered in the)
(1) Medicine Name: Devdarubaladi Taila, Reference: Sahasrayogam Taila prakaran, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having classical signs and symptoms of Katigata Vata(Low Back Pain)
Katishula(Lumbar Pain) for 3 months or more than 3 months, Katigraha(Restriction of movement), Sparsha Asahatva(Tenderness) Ref.GadaNigraha |
|
| ExclusionCriteria |
| Details |
Known case of Congenital structural deformities of spine
Known case of Vertebral compression fracture
Known case of Rheumatoid Arthritis, Ankylosing spondylosis
Known case of Aamvata and Vatarakta
Pregnant females |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Devdarubaladi Taila Matra Basti in Katishula(pain reduction) of Katigata Vata(Low Back Pain) by VAS Scale. |
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Devdarubaladi Taila Matra Basti in Katigraha(restriction of movement) of Katigata Vata(Low Back Pain) by using Coin test |
7 days |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
20/05/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
A Single Arm Clinical Study
to evaluate the efficacy of Devdarubaladi Taila Matra Basti in the management
of Katigata Vata (Low back pain). By administering Devdarubaladi
Taila Matra Basti (60ml) in total-35 patients for duration of 7 consecutive
days. It will be administered just
after lunch, once a day. Assessment - on 1st and 7th
day. Duration of study -18 months. Further final conclusion will
be drawn on the basis of statistical methods. |