| CTRI Number |
CTRI/2024/06/068396 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
04/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Management of Lumbar Spondylosis in Ayurvedic intervention |
|
Scientific Title of Study
|
A Clinical study on katigraha wsr to lumbar spondylosis and its management with erandadi kwatha and shatapushpadi lepa |
| 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 Sonali Mishra |
| Designation |
PG SCHOLAR |
| Affiliation |
Gopabandhu Ayurveda Mahavidyalaya |
| Address |
Gopabandhu Ayurveda Mahavidyalaya Department of Kayachikitsa
VIP Road Puri
Puri
ORISSA
752002
India |
| Phone |
7008461738 |
| Fax |
|
| Email |
msonalimishra1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Pragya Priyadarsini Mallik |
| Designation |
Professor and HOD |
| Affiliation |
Gopabandhu Ayurveda Mahavidyalaya |
| Address |
Gopabandhu Ayurveda Mahavidyalaya Department of Kayachikitsa
VIP Road Puri
Puri
ORISSA
752002
India |
| Phone |
9437212898 |
| Fax |
|
| Email |
pragya2506@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Pragya Priyadarsini Mallik |
| Designation |
Professor and HOD |
| Affiliation |
Gopabandhu Ayurveda Mahavidyalaya |
| Address |
Gopabandhu Ayurveda Mahavidyalaya Department of Kayachikitsa
VIP Road Puri
Puri
ORISSA
752002
India |
| Phone |
9437212898 |
| Fax |
|
| Email |
pragya2506@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD of PG Department of Kayachikitsa Gopabandhu Ayurveda Mahavidyalaya Puri |
|
|
Primary Sponsor
|
| Name |
Dr Sonali Mishra |
| Address |
PG Department of Kayachikitsa Gopabandhu Ayurveda Mahavidyalaya and Hospital Puri Odisha |
| 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 |
| Dr Sonali Mishra |
Gopabandhu Ayurveda Mahavidyalaya |
OPD and IPD of PG Department of Kayachikitsa Gopabandhu Ayurveda Mahavidyalaya VIP Road Puri
Puri
ORISSA |
7008461738
msonalimishra1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Gopabandhu Ayurveda Mahavidyalaya and Hospital,Puri |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M00-M99||Diseases of the musculoskeletal system and connective tissue. Ayurveda Condition: ASTHIKSHAYAH, (2) ICD-10 Condition:M00-M99||Diseases of the musculoskeletal system and connective tissue. Ayurveda Condition: ASTHIGATAVATAH, (3) ICD-10 Condition:M00-M99||Diseases of the musculoskeletal system and connective tissue. Ayurveda Condition: ASTHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Erandadi kwatha, Reference: Sarangadhara Samhita Madhyama Khanda, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 100(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Eranda taila Hingu Yava kshara Saindhava), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shatapushpadi lepa, Reference: Yoga ratnakar, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient having sign and symptoms of Katigraha
Patient having sign and symptoms of Lumbar Spondylosis |
|
| ExclusionCriteria |
| Details |
Age less than 20yrs and more than 70yrs
Traumatic and post surgical backache
Lumbago sciatica syndrome
Lumbar spondylisthesis
Lumbarspondylolisthesis
Ankylosing Spondylitis
Rheumatoid arthritis
Psoriatic arthritis
Gouty arthritis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce sign and symptoms of Lumbar Spondylosis |
30days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To maintain ESR level and range of movement in Lumbar Spondylosis |
30days |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/06/2024 |
| 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="0"
Months="1"
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
|
This study is a randomized single blind clinical trial of 1month duration to compare efficacy of erandadi kwatha internally and shatapushpadi lepa externally in katigraha w.s.r to lumbar spondylosis. Follow up in15days. The medicine described by Samhita can be effectively control the clinical symptoms of Katigraha w.s.r to Lumbar Spondylosis. |