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CTRI Number  CTRI/2025/07/090535 [Registered on: 09/07/2025] Trial Registered Prospectively
Last Modified On: 09/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Physiotherapy and ayurvedic medicine for low back pain 
Scientific Title of Study   Comparative Study on Lumbar Spondylosis Management by Physiotherapy and Vatari Gugglulu: A Classical Anti-inflammatory Medicine 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mohammad Shahadat Hossain 
Designation  Ph.D. student 
Affiliation  Jahangirnagar University 
Address  Department of Pharmacy, Jahangirnagar University, Savar, Dhaka-1342, Bangladesh



1342
Other 
Phone  8801615451525  
Fax    
Email  shahadatphysio488@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mohammad Shahadat Hossain 
Designation  Ph.D. student 
Affiliation  Jahangirnagar University 
Address  Department of Pharmacy, Jahangirnagar University, Savar, Dhaka-1342, Bangladesh



1342
Other 
Phone  8801615451525  
Fax    
Email  shahadatphysio488@gmail.com  
 
Details of Contact Person
Public Query  
Name  Professor Dr. Masum Shahriar 
Designation  Professor  
Affiliation  Jahangirnagar University 
Address  Department of Pharmacy, Jahangirnagar University, Savar, Dhaka-1342, Bangladesh



1342
Other 
Phone  8801818052358  
Fax    
Email  masum_shahriar@juniv.edu  
 
Source of Monetary or Material Support  
Department of Pharmacy, Jahangirnagar University, Savar, Dhaka-1342, Bangladesh 
 
Primary Sponsor  
Name  Centre for Autism and Rehabilitation for Persons with Disabilities (CARD) 
Address  Level 2, ASPC academic building, U-64, Mohammadpur, Dhaka, Bangladesh 
Type of Sponsor  Other [Philanthropic organization in Disability] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Bangladesh  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mohammad Afzal Hossain  Agrani Specialized Hospital  Outpatient Physiotherapy unit, Level-2, Clinical building, ASPC manipulation Therapy, Mohammadpur, Dhaka, Bangladesh

 		 880 1714014628

shahadatphysio488@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IRB of Department of Physiotherapy & Rehabilitation, JUST  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M479||Spondylosis, unspecified. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-PhysiotherapyPhysiotherapy as manual therapy and exercise in the Structural Diagnosis and Management (SDM) concept, Doses: Manual therapy and exercise therapy at the center for 45 minutes, every day for 14 days. Supervised home exercise once for 30 minutes, every day, for 76 days. Total duration 90 days.
2Intervention ArmDrugClassical(1) Medicine Name: Vatari Gugglulu, Reference: Vatari Gugglulu, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: prescribed by Ayurved physician
3Comparator Arm (Non Ayurveda)-Conventional careConventional care includes Non-steroidal anti-inflammatory drugs (NSAIDs) prescribed by a registered physician, and any specific DGDA-approved brand name for all patients. Reference: North American Spine Society Guideline, Route: Oral, Dosage form: Tablet, Dose: 500 (mg), Frequency: bd, Duration: 10 days, Additional information: Added anti-ulcerent 20 mg in bd. Calcium and vitamin D supplements are prescribed by a registered physician, and any specific DGDA-approved brand name is recommended for all patients. Reference: DGDA, Bangladesh, Route: Oral, Dosage form: Tablet, Dose: 500 (mg) coral calcium and 200IU of vitamin D, Frequency: od, Duration: 80 days, Additional information: Added lifestyle advice.
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Low back pain for more than 3 months; and/or associated radiating pain at buttock or lower limbs in one or both sides, Radiological evidence of Vertebral body degeneration, osteophyte lipping, marginal osteophytes, reduced intervertebral space, calcified anterior longitudinal ligament of muscle spasm causing straitening of lumbar curvature evident by Digital X-ray of Lumbo-sacral spine Anterior-posterior and lateral view or narrowing or degeneration of facet join evident in X-ray of lumbar spine oblique view, Pain level at 100-milimeter visual analogue scale between 20 and 70 (Mild to moderate), Osteoporesis diagnosed by Bone mineral density test, Conesent for participating the trial voluntarily
 
 
ExclusionCriteria 
Details  Neurological sign of duramater or nerve root compression due to disc herniation, Hematology and toxicology tests indicating unsitable for trial interventions, Any history of surgery of any part of spine, Drop-out within the first week of recruitment.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain according to pain pressure threshhold (PPT) measured by pressure algometer, Pain measured in 5 positions (supine lying, more than 15 minutes standing, siting, walking and daily activities) by 100mm Visual Analogue Scale, Bone mineral density (BMD)  90 days 
 
Secondary Outcome  
Outcome  TimePoints 
Fear avoidance belief that limits people to be involved in functional activities due to pain by Fear avoidance belief questionnaire scale, Disability due to LBP by Oswestry disability index scale, Serum vitamin D3 level, Serum B12 level
 		 90 days 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="0" 
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)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/07/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Applicable 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [shahadatphysio488@gmail.com].

  6. For how long will this data be available start date provided 01-12-2025 and end date provided 31-12-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Lumbar Spondylosis is a global concern for increasing prevalence, longer duration, treatment cost, polypharmacy, absence in work, and disease burden. Lumbar spondylosis is the commonest form of degenerative low back pain and accounts for a wide range of interventions. Recent reports on global burden of disease indicates people living in the lower-middle income countries of Asia, specifically southeast Asia have the highest age-standard prevalence of low back pain, mostly degenerative low back pain. Conventional medicine addresses the painful impairments but fails to address the episodic disability, and also merely responsive to early degeneration. Physiotherapy, combined with manual therapy, exercise therapy, and lifestyle modification addresses the painful functional limitations, and prevention of early degeneration but lacks high quality evidence compared to medication. Classical medicines also have clinical outcome on the painful and degenerative issues, hence there are limited research in this field.

The proposed study will fill-up the research gap of high quality randomized clinical trial comparing physiotherapy, classical medicine and conventional medicine on painful functional limitations, fear avoidance belief on activities, and episodic disability for people having degenerative low back pain. The outcome will be evaluated through short term and long-term outcomes. The implication of this study will guide clinicians in evidence-based practice in a low-resource country and improve the healthcare services towards the people having degenerative low back pain. The study will also facilitate future research and funding in multi-center large-scale clinical trials. This study has hematology and toxicology evaluation, so the outcome will also be evaluated as safety of interventions, and cost-effectiveness.  

 
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