| CTRI Number |
CTRI/2023/08/056799 [Registered on: 23/08/2023] Trial Registered Prospectively |
| Last Modified On: |
22/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see the effect of yoga and ayurveda in Lower Backpain and stress |
|
Scientific Title of Study
|
Evaluation of yoga Practice and Ayurvedic Compound in the management of Katishool(lower backache) and mental stress |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhishek Maurya |
| Designation |
Ph.D Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Sangyaharan, Dhanvantri Bhawan, IMS BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9456574125 |
| Fax |
|
| Email |
abhi_shekhar@bhu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Kuldeep Kumar Pandey |
| Designation |
Prof. and Head |
| Affiliation |
Banaras Hindu University |
| Address |
Ayurved Bhavan
Department of Sangyaharan
Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415251556 |
| Fax |
|
| Email |
pandeykk@bhu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Prof Kuldeep Kumar Pandey |
| Designation |
Prof. and Head |
| Affiliation |
Banaras Hindu University |
| Address |
Ayurved Bhavan
Department of Sangyaharan
Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415251556 |
| Fax |
|
| Email |
pandeykk@bhu.ac.in |
|
|
Source of Monetary or Material Support
|
| Department of Sangyaharan, IMS BHU |
|
|
Primary Sponsor
|
| Name |
Institute of Medical Science |
| Address |
Department of Sangyahran Dhanvantari Bhavan IMS BHU |
| Type of Sponsor |
Government medical college |
|
|
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 Kuldeep Kumar Pandey |
Sir Sundar Lal Hospital, IMS, BHU |
Room number 15, Department of Sangyaharan, Ayurvedic wing
Varanasi
UTTAR PRADESH |
8318884863
pandeykk@bhu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M959||Acquired deformity of musculoskeletal system, unspecified. Ayurveda Condition: sufferings from katishool(Low Backache) with mental stress, (2) ICD-10 Condition:M955||Acquired deformity of pelvis. Ayurveda Condition: KATIKATARUNA-MARMAVIDDHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Compound of Shankhpushpi, Brahmi, Ashwagandha, Reference: P.V. Sharma, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 300(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Compound of Paarijat,Sahjan,Nirgundi and Rashna, Reference: P.V. Sharma, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 300(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: na, Ritucarya: na, Acara Rasayana:na, Other:na, Pathya/Apathya:no, Pathya:, Apathya: | | 3 | Comparator Arm (Non Ayurveda) | | - | Yoga | Specific Physical, breathing and meditation intervention will be given |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
65.00 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 |
Visible analog scale
Stress Questionnaire
Oswestry low back pain Disability Questionnaire |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of Life |
45 days |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
01/09/2023 |
| 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="3"
Months="0"
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 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 Sample size of 135 Patients and it will be distributed in 3 arms study 45 patients simultaneously . Results will be helpful for further Alternative therapy and its effects in modern world. |