| CTRI Number |
CTRI/2022/12/047911 [Registered on: 06/12/2022] Trial Registered Prospectively |
| Last Modified On: |
15/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [MATRABASTI] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Study to Assess the Efficacy of Mulaka taila Matrabasti and Shiva guggulu over Sahachara taila Matrabasti and Rasna guggulu in patients with Gridhrasi(Sciatica) |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study to Assess the Efficacy of Mulaka taila Matrabasti and Shiva guggulu Over Sahachara taila Matrabasti and Rasna guggulu in the management of Gridhrasi(Sciatica). |
| 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 Ashwini Banappa Nandagaon |
| Designation |
BAMS PG Scholar |
| Affiliation |
BLDEAs AVS Ayurveda Mahavidylaya, |
| Address |
PG Scholar, Department of Kayachikitsa, BLDEAs AVS Ayurveda Mahavidyalaya, Hospital and Research centre Vijayapur- 586109 Karnataka India
Bijapur
KARNATAKA
586109
India |
| Phone |
9008611484 |
| Fax |
|
| Email |
ashwininandagaon207@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Kadlimatti |
| Designation |
Principal and Professor |
| Affiliation |
BLDEAs AVS Ayurveda Mahavidyalaya |
| Address |
Principal and Professor Department of Kayachikitsa, BLDEAs AVS Ayurveda Mahavidyalaya Hospital and Reseach centre Vijayapur - 586109 Karnataka India
Bijapur
KARNATAKA
586109
India |
| Phone |
8970744656 |
| Fax |
|
| Email |
ayursanjay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Kadlimatti |
| Designation |
Principal and Professor |
| Affiliation |
BLDEAs AVS Ayurveda Mahavidyalaya |
| Address |
Principal and Professor Department of Kayachikitsa, BLDEAs AVS Ayurveda Mahavidyalaya Hospital and Reseach centre Vijayapur - 586109 Karnataka India
Bijapur
KARNATAKA
586109
India |
| Phone |
8970744656 |
| Fax |
|
| Email |
ayursanjay@gmail.com |
|
|
Source of Monetary or Material Support
|
| BLDEAS AVS AYURVEDA MAHAVIDYALAYA VIJAYAPUR |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Ashwini Banappa Nandagaon |
BLDEAs AVS Ayrveda Hospital |
Kayachikitsa 10, BLDEAS AVS Ayurveda Mahavidyalaya Hospital and Research centre Vijayapur - 586109 Karnataka India
Bijapur
KARNATAKA |
9008611484
ashwininandagaon207@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:G541||Lumbosacral plexus disorders. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: SHIVA GUGGULU, Reference: BHAISHAJYA RATNAVALI, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: SUKHOSHNA JALA), Additional Information: | | 2 | Intervention Arm | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: charaka samhita, Procedure details: matrabasti with mulaka taila 60ml after food)
(1) Medicine Name: mulaka taila, Reference: charaka samhita, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 7 Days | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: rasna guggulu, Reference: Bhavaprakasha , Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: sukhoshna jala), Additional Information: - | | 4 | Comparator Arm | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: charaka samhita , Procedure details: matrabasti with sahachara taila 60ml after food)
(1) Medicine Name: sahachara taila, Reference: charaka samhita , Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
subjects presenting with the classical signs and symptoms og gridhrasi
subjects should not be on any other medicine for gridhrasi
subjects willing and able to participate in the study |
|
| ExclusionCriteria |
| Details |
known case of uncontrolled diabetes mellitus, tuberculosis of spine and neoplastic conditions of spine.
trauma of spine
congenital disorders like spina bifida
pregnancy and lactating mothers
subjects who are unfit for basti |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction in pain |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in SLR test |
28 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 2 |
|
Date of First Enrollment (India)
|
12/06/2023 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
this study is randomized comparative clinical study to assess the efficacy of mulaka taila matrabasti and shiva guggulu over sahachara taila matrabasti and rasna guggulu in the management of gridhrasi that will be conducted in BLDEAS AVS Ayurveda Mahavidyalaya Hospital and Research Centre, Vijayapur - 586109 Karnataka, India |