| CTRI Number |
CTRI/2025/06/089750 [Registered on: 27/06/2025] Trial Registered Prospectively |
| Last Modified On: |
24/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Integrated Approach Along with Ayurvedic Formulation (Peedanil Gold) in Chronic Low Back Pain. |
|
Scientific Title of Study
|
Evaluating the Effect of Integrated Approach Along with Ayurvedic Formulation (Peedanil Gold) in Chronic Low Back Pain: Prospective, Open Label, Single Arm, Observational Study. |
| 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 Ajay Singh |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Ayurveda Hospital |
| Address |
OPD No 31
Department of Panchkarma Patanjali Yogpeeth Maharshi Dayanand Gram Delhi Haridwar National Highway Near Bahadrabad Haridwar Uttarakhand
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9039402300 |
| Fax |
|
| Email |
drajaysingh82@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Singh |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Ayurveda Hospital |
| Address |
OPD No 31
Department of Panchkarma Patanjali Yogpeeth Maharshi Dayanand Gram Delhi Haridwar National Highway Near Bahadrabad Haridwar Uttarakhand
UTTARANCHAL
249405
India |
| Phone |
9039402300 |
| Fax |
|
| Email |
drajaysingh82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Singh |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Ayurveda Hospital |
| Address |
OPD No 31
Department of Panchkarma Patanjali Yogpeeth Maharshi Dayanand Gram Delhi Haridwar National Highway Near Bahadrabad Haridwar Uttarakhand
UTTARANCHAL
249405
India |
| Phone |
9039402300 |
| Fax |
|
| Email |
drajaysingh82@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Research Foundation Governed by Patanjali Research Foundation Trust
NH 58 Near Bahadrabad Haridwar Uttarakhand 249405 India
|
|
|
Primary Sponsor
|
| Name |
Patanjali Research Foundation |
| Address |
NH 58 Near Bahadrabad Haridwar Uttarakhand 249405 India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ajay Singh |
Patanjali Ayurveda Hospital |
OPD No 31
Department of Panchkarma Patanjali Yogpeeth Maharshi Dayanand Gram Delhi Haridwar National Highway Near Bahadrabad Haridwar 249405 Uttarakhand India
Hardwar
UTTARANCHAL |
9039402300
drajaysingh82@gmail.com |
| Dr Ajay Singh |
Patanjali Wellness |
OPD No 17
Department of Panchkarma Patanjali Wellness Delhi Haridwar National Highway Near Bahadrabad Haridwar 249405 Uttarakhand India
Hardwar
UTTARANCHAL |
9039402300
drajaysingh82@gmail.com |
| Dr Ajay Singh |
Patanjali Yoggram |
OPD No 13
Department of Panchkarma Patanjali Yoggram Yog Naturopathy Panchkarma Treatment and Research Centre Yoggram Village Aurangabad Near SIDCUL Roshnabad Haridwar 249402 Uttarakhand India
Hardwar
UTTARANCHAL |
9039402300
drajaysingh82@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| PATANJALI AYURVED COLLEGE ETHICS COMMITTEE |
Approved |
| PATANJALI AYURVED COLLEGE ETHICS COMMITTEE |
Approved |
| PATANJALI AYURVED COLLEGE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M545||Low back pain. Ayurveda Condition: TRIKASULAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who had been experiencing chronic back pain that had been pre diagnosed for longer than three months.
Patients with acute musculoskeletal spasm with low back pain due to Lumbar spondylosis osteoarthritis Acute lumbosacral strain Blunt superficial trauma prolapsed intervertebral disc.
Patients who are ready to give written informed consent and comply with the protocol requirements.
|
|
| ExclusionCriteria |
| Details |
Previous back surgery Diabetic and diagnosed with CLBP as a result of organic spine diseases, such as primary or secondary cancer chronic infections as identified by lumbar spine X rays chronic diseases like tuberculosis renal disease hemorrhagic sickness inflammatory low back pain and acute rheumatoid arthritis were not included in this study.
Patients with acute muscle spasms who need parenteral therapy surgery or hospital admissions for management.
Pregnant or lactating women.
Patients are unwilling or unable to comply with the study procedures.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in the severity of pain by using Visual Analogue Scale and disability level of back pain by using The Oswestry Disability Index. |
From Baseline to Day 7 Day 30 Day 60 and Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in the Quality of life by using WHOQOL-BREF |
From Baseline to Day 7 Day 30 Day 60 and Day 90 |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
21/07/2025 |
| 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) |
Open to Recruitment |
|
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
is a prospective, open-label, single-arm, observational study. Subjects will be
screened on the basis of Inclusion/Exclusion criteria and enrolled after
obtaining written Informed consent. After enrollment, the investigator will plan
7 days Panchkarma procedure, yoga and naturopathy treatment along with oral
medication Peedanil Gold. After 7 days the subject will be continue Peedanil Gold oral medication for next 3 months and the severity of pain and quality of life will be assessed by using specfic questionnaire at Day 30, Day 60 and Day 90 interval.. |