| CTRI Number |
CTRI/2024/07/070569 [Registered on: 13/07/2024] Trial Registered Prospectively |
| Last Modified On: |
12/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of Dwipanchamooladhya Taila Katibasti and Vatariguggulu over Ksheerabala Taila Katibasti and Trayodashanga Guggulu in low Backpain |
|
Scientific Title of Study
|
A Randomized comparative clinical study to assess the efficacy of Dwipanchamooladhya taila Katibasti and Vatari Guggulu over Ksheerabala taila Katibasti and Trayodashanga Guggulu in the management of Katigatavata (low backpain) |
| 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 Savitri Masali |
| Designation |
BAMS PG Scholar |
| Affiliation |
BLDEAs AVS Ayurveda Mahavidyalaya Vijayapur-586109 Karnataka India |
| Address |
Department of Kayachikitsa, BLDEAs AVS Ayurveda Mahavidyalaya Vijayapura-586109 Karnataka India
Bijapur
KARNATAKA
586109
India |
| Phone |
8217233865 |
| Fax |
|
| Email |
savitrijanumasali3333@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay M Kadlimatti |
| Designation |
Principal and Professor |
| Affiliation |
BLDEAs AVS Ayurveda Mahavidyalaya Vijayapur-586109 Karnataka India |
| Address |
Department of Kayachikitsa, BLDEAs AVS Ayurveda Mahavidyalaya Vijayapura-586109 Karnataka India
Bijapur
KARNATAKA
586109
India |
| Phone |
8970744656 |
| Fax |
|
| Email |
ayursanjay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay M Kadlimatti |
| Designation |
Principal and Professor |
| Affiliation |
BLDEAs AVS Ayurveda Mahavidyalaya Vijayapur-586109 Karnataka India |
| Address |
Department of Kayachikitsa, BLDEAs AVS Ayurveda Mahavidyalaya Vijayapura-586109 Karnataka India
Bijapur
KARNATAKA
586109
India |
| Phone |
8970744656 |
| Fax |
|
| Email |
ayursanjay@gmail.com |
|
|
Source of Monetary or Material Support
|
| BLDEAs AVS Ayurveda Mahavidyalaya Hospital and Research centre Vijayapur-586109 Karnataka India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [Non sponsored study, Academic Dissertation] |
|
|
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 Savitri Masali |
BLDEAs AVS Ayurveda Hospital |
Department of kayachikitsa, Room no- 10, BLDEAs AVS Ayurveda Mahavidyalaya Hospital and Research centre Vijayapur -586109 Karnataka India
Bijapur
KARNATAKA |
8217233865
savitrijanumasali3333@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee BLDEAs AVS Ayurveda Mahavidyalaya,Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:8||Other Procedures. Ayurveda Condition: GRUDHRASI, (2) ICD-10 Condition:M95||Other acquired deformities of musculoskeletal system and connective tissue. Ayurveda Condition: GRUDHRASI, (3) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | kaTibastiH, कटिबसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: nil, Procedure details: Katibasti with Dwipanchamooladhya taila method- by using katibasti Ring placing over Kati region Position-Prone position Duration- 30 mins for 7 days. ))
(1) Medicine Name: Dwipanchamooladhya taila, Reference: Bhaishajya ratnavali 29 th chaptershloka no-228,, Route: Topical, Dosage Form: Taila, Dose: 400(ml), Frequency: od, Duration: 7 Days(2) Medicine Name: VatariGuggulu, Reference: Bhaishajya ratnavali 29 th chaptershloka no-152-155, Route: Oral, Dosage Form: Guggulu, Dose: 500(mg), Frequency: bd, Duration: 4 Weeks | | 2 | Comparator Arm | Procedure | - | kaTibastiH, कटिबसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: nil, Procedure details: Katibasti Ksirabala taila method- by using katibasti Ring, placing the ring over Kati region. Position-Prone position
Duration- 30 minutes for each day, f0r 7 days)
(1) Medicine Name: Kshirabala taila, Reference: Sahasrayoga with Dharakalpa 4th chapter,, Route: Topical, Dosage Form: Taila, Dose: 400(ml), Frequency: od, Duration: 7 Days(2) Medicine Name: Trayodashanga Guggulu, Reference: Bhaishajya Ratnavali, 26th chapter, shoka no-98-101, Route: Oral, Dosage Form: Guggulu, Dose: 500(mg), Frequency: bd, Duration: 4 Weeks |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Subjects presenting with the classical signs and symptoms of katigatavata.
2) Subjects of either sex, irrespective to religion, socio economic status, occupation and aged between 20 – 60 years.
3) Subjects who are able to participate in the study and who will sign for informed consent.
|
|
| ExclusionCriteria |
| Details |
1) Patients suffering from acute systemic disorders as well as other known case of major illness.
2) Neoplastic conditions of spine, Pot’s spine and Trauma of spine.
3) Pregnant women and Lactating mother will be excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Pain and stiffness |
35 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Visual Analogue scale, Range of movement and Tenderness in spine |
35 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/08/2024 |
| 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="4"
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
|
The study is Randomized comparative clinical study to assess the efficacy of Dwipanchamooladhy Taila Kati Basti and vatari Guggulu over Ksheerabala taila Katibasti and Trayodashnaga Guggulu in the management of Katigatavata that will be conducted in BLDEAs AVS Ayurveda Mahavidyalaya Hospital and Research centre Vijayapur-586109 Karnataka India
|