| CTRI Number |
CTRI/2023/12/060597 [Registered on: 20/12/2023] Trial Registered Prospectively |
| Last Modified On: |
19/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To find the effect of yogic practices and agnikarma on chronic lower back pain |
|
Scientific Title of Study
|
Evaluation of yogic practices and agnikarma on chronic lower backache |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NEHA |
| Designation |
Ph.D. Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Sangyaharan, Faculty of Ayurveda Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7309601587 |
| Fax |
|
| Email |
n130798@bhu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr RK Jaiswal |
| Designation |
Assistant Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Sangyaharan, Faculty of Ayurveda Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415624830 |
| Fax |
|
| Email |
rkj41a@bhu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Neha |
| Designation |
Ph.D. Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Sangyaharan, Faculty of Ayurveda Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7309601587 |
| Fax |
|
| Email |
n130798@bhu.ac.in |
|
|
Source of Monetary or Material Support
|
| Department of Sangyaharan, Institute of Medical Science Banaras Hindu University |
|
|
Primary Sponsor
|
| Name |
Institute of medical science |
| Address |
Department of Sangyaharan faculty of ayurveda Institute of Medical Science Banaras Hindu University |
| Type of Sponsor |
Other [Banaras Hindu University] |
|
|
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 RKJaiswal |
Sir Sunder Lal Hospital IMS BHU Varanasi |
OPD No.15,16A Department of Sangyaharan Faculty of Ayurveda
Varanasi
UTTAR PRADESH |
9415624830
rkj41a@bhu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Institute of medical science Banaras Hindu University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: shool, (2) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Trayodashang guggulu, Reference: Bhaisajyaratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
In this study we will include patients on OPD
Patients ready to sign Consent form
|
|
| ExclusionCriteria |
| Details |
Severe patients in disease
got operated
not bed ridden or unable to preform physical practices |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analog scale
The Oswestry Disability Index (ODI) Version 2.0 or Oswestry Low Back Pain Disability Questionnaire |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life |
45 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 |
|
Date of First Enrollment (India)
|
01/01/2024 |
| 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="3"
Months="0"
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
|
The evaluation of using yogic practices and herbal compounds to address lower backache associated with mental stress involves considering both traditional wisdom and scientific evidence. We are taking a sample size of 80 patients and it will be distributed in 2 arms study of 40 patients simultaneously. Results will be helpful for further alternative therapy and its effects on the modern world. |