CTRI/2025/11/097409 [Registered on: 13/11/2025] Trial Registered Prospectively
Last Modified On:
11/11/2025
Post Graduate Thesis
No
Type of Trial
Observational
Type of Study
Cohort Study
Study Design
Other
Public Title of Study
Study on the Effectiveness of ResearchAyu Spineveda Ayurvedic Therapy for Spine Osteoporosis and Spondylosis
Scientific Title of Study
EFFECTIVENESS OF RESEARCHAYU SPINOVEDA TREATMENT STRATEGY IN SPINE OSTEOPOROSIS AND SPONDYLOSIS: A RETROSPECTIVE
MULTICENTRIC COHORT STUDY
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
TCC-0809-2025-02
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Poorva Sawant
Designation
HOD of Regeneration Specialist ResearchAyu Kneeveda
Affiliation
ResearchAyu
Address
ResearchAyu Mate Heights 4th Floor Near Kalika Dairy Mahapatra Road Next to Noble Hospital Hadapsar Pune Maharashtra
Mumbai MAHARASHTRA 411013 India
Phone
9082679565
Fax
Email
poorva.sawant@healthylifeinnovation.com
Details of Contact Person Scientific Query
Name
Dr Kadambari A Tupe
Designation
Co Pi
Affiliation
ResearchAyu
Address
ResearchAyu Mate Heights 4th Floor Near Kalika Dairy Mahapatra Road Next to Noble Hospital Hadapsar Pune Maharashtra
Mumbai MAHARASHTRA 411013 India
Phone
7276063719
Fax
Email
kadambari.tupe@healthylifeinnovation.com
Details of Contact Person Public Query
Name
Dr Kadambari A Tupe
Designation
Co Pi
Affiliation
ResearchAyu
Address
ResearchAyu Mate Heights 4th Floor Near Kalika Dairy Mahapatra Road Next to Noble Hospital Hadapsar Pune Maharashtra
Mumbai MAHARASHTRA 411013 India
Phone
7276063719
Fax
Email
kadambari.tupe@healthylifeinnovation.com
Source of Monetary or Material Support
Tech clinic connect.
127/128, Vision Galleria, Pimple Saudagar, Sangavi, Pune, Pune City, Maharashtra, India, 411027
Primary Sponsor
Name
Tech clinic connect.
Address
TECHCLINIC CONNECT PRIVATE LIMITED is 127/128, Vision Galleria, Pimple Saudagar, Sangavi, Pune, Pune City, Maharashtra, India, 411027
Type of Sponsor
Research institution and hospital
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 16
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Kadambari A Tupe
ResearchAyu
Office no. 101, Building name - NIRDHAR CHS LTD. First floor, Nearby Suvarna bus stop and Lokmanya Multipurpose Coop Society Ltd, Shimpoli Road, Borivali West - 400092 Mumbai MAHARASHTRA
7276063719
kadambari.tupe@healthylifeinnovation.com
Dr Kadambari A Tupe
ResearchAyu
05 1, 5th Floor, F Wing, KK Market Business Premises, Satara Road, Dhankawadi, Pune Pune MAHARASHTRA
7276063719
Kadambari.tupe@healthylifeinnovations.com
Dr Kadambari A Tupe
ResearchAyu
Survey No. 94/4, First Floor, Venture, Plot No. 5/2/6, Paud Road, Left Bhusari Colony, Kothrud, Pune – 411044 Pune MAHARASHTRA
7276063719
kadambari.tupe@healthylifeinnovation.com
Dr Poorva Sawant
ResearchAyu
Office No. 204, 205, 206, B Wing, 2nd Floor, Shankardhan Plaza, Near Mehul Talkies, Above Yes Bank, J.N. Road, Mulund West, Mumbai - 400080 Mumbai MAHARASHTRA
9082679565
poorva.sawant@healthylifeinnovation.com
Dr Poorva Sawant
ResearchAyu
Office No. 104 and 401, 1st Floor, Kesarinath Bldg, S V Road, Opp. Vijay Sales, Near Filmistan Studio, Goregaon West - 400067 Mumbai MAHARASHTRA
9082679565
poorva.sawant@healthylifeinnovation.com
Dr Poorva Sawant
ResearchAyu
Vastushilp Co-op. Hsg. Society Ltd, Rambaug Lane No.4, Near Janta Bank, Kalyan West - 421301 Mumbai MAHARASHTRA
9082679565
poorva.sawant@healthylifeinnovation.com
Dr Poorva Sawant
ResearchAyu
Devi Apartment Plot No. 189, Sector 12, Ground Floor, Near Saraswat Bank, Blue Diamond Hotel, Vashi – 400703 Mumbai MAHARASHTRA
9082679565
poorva.sawant@healthylifeinnovation.com
Dr Poorva Sawant
ResearchAyu
ResearchAyu Mate Heights 4th Floor Near Kalika Dairy Mahapatra Road Next to Noble Hospital Hadapsar Pune Maharashtra 411028 Pune MAHARASHTRA
9082679565
poorva.sawant@healthylifeinnovation.com
Dr Poorva Sawant
ResearchAyu
Tated Horizon, Ground Floor, Opp. St. Ursula High School, Near Savali Hotel/NIBR College of Hotel Management, Nigadi Chowk Pune MAHARASHTRA
501 and 502 B Wing Royal Enclave Parsi Panchayat Road, above apple chemist, near Sona Udyog, Old Nagardas, Andheri East Mumbai - 400069 Mumbai MAHARASHTRA
Patients of either sex aged between 30 to 85 years.
Diagnosed cases of degenerative spine diseases such as spondylosis (cervical, lumbar, or combined) and/or osteoporosis, confirmed by clinical and radiological findings.
Patients who have undergone the ResearchAyu Spineveda Treatment Strategy (STS) between January 2024 and February 2025 at participating centers.
Availability of complete baseline and follow-up data in the patient medical records.
Patients who had provided written informed consent for treatment and use of anonymized clinical data for research.
ExclusionCriteria
Details
Patients below 30 years or above 85 years of age.
Patients with infective, inflammatory, or traumatic spine disorders (such as Pott’s spine, ankylosing spondylitis, or fractures).
Patients with systemic rheumatoid arthritis, rheumatic heart disease, or autoimmune disorders likely to confound degenerative findings.
History of spine surgery, malignancy, or chronic corticosteroid use.
Pregnant or lactating women.
Patients with incomplete or missing baseline or follow-up data.
Patients receiving concurrent Panchakarma or Ayurvedic interventions not part of the STS protocol during the study period.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
In our study, time points refer to the scheduled intervals at which outcome assessments will be carried out. All clinical outcomes (including VAS pain score, spinal range of motion, and morning stiffness) will be evaluated at baseline (before initiation of treatment), at 4 weeks, and at 8 weeks. These defined time points will allow comparison of patient outcomes over the treatment duration to assess the effectiveness of the Spinoveda treatment strategy.
In our study, time points refer to the scheduled intervals at which outcome assessments will be carried out. All clinical outcomes (including VAS pain score, spinal range of motion, and morning stiffness) will be evaluated at baseline (before initiation of treatment), at 4 weeks, and at 8 weeks. These defined time points will allow comparison of patient outcomes over the treatment duration to assess the effectiveness of the Spinoveda treatment strategy.
Secondary Outcome
Outcome
TimePoints
Change in lumbar spine and femoral bone mineral density (BMD) as recorded in DEXA reports
Baseline and after 6 months of therapy
Target Sample Size
Total Sample Size="180" Sample Size from India="180" 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)
26/11/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
26/11/2025
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="0" Months="6" 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 study titled Effectiveness of ResearchAyu Spineveda Treatment Strategy in Spine Osteoporosis and Spondylosis A Retrospective Multicentric Cohort Study aims to evaluate the clinical outcomes of patients who have received the Spineveda Treatment Strategy STS at multiple ResearchAyu centers. This retrospective observational analysis uses existing patient medical records to assess improvement in pain, mobility, and bone health parameters among patients diagnosed with spondylosis and osteoporosis.
Eligible patients of either gender aged between 30 and 85 years with documented diagnosis and follow up data are included. Data variables include demographic details, baseline disease profile, treatment details, Visual Analogue Scale VAS scores, Oswestry Disability Index ODI, bone mineral density reports, and biochemical parameters such as calcium and vitamin D.
The analysis measures changes in pain scores, improvement in functional ability, and quality of life after completion of the Spineveda treatment. The study is expected to provide real world evidence on the effectiveness and safety of the Ayurvedic Spineveda protocol in managing degenerative spine disorders and osteoporosis, supporting integrative and evidence based management approaches for chronic musculoskeletal conditions.