| CTRI Number |
CTRI/2026/04/109578 [Registered on: 28/04/2026] Trial Registered Prospectively |
| Last Modified On: |
24/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to evaluate whether a nutritional supplement containing Cissus quadrangularis helps improve bone fracture healing in adults in India |
|
Scientific Title of Study
|
A prospective multicentre real world study to assess the effectiveness and safety of Oral Nutritional Supplement (ONS) containing Cissus Quadrangularis (CQ) in fracture healing in adults with fractures, in India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajeev Raman |
| Designation |
Consultant Orthopaedic |
| Affiliation |
Joint & Bone Care Hospital |
| Address |
DD-35, 2nd Avenue, DD Block,
Salt Lake City Sector 1
Kolkata
WEST BENGAL
700064
India |
| Phone |
8420244544 |
| Fax |
|
| Email |
drrajeevraman@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajeev Raman |
| Designation |
Consultant Orthopaedic |
| Affiliation |
Joint & Bone Care Hospital |
| Address |
DD-35, 2nd Avenue, DD Block,
Salt Lake City Sector 1
Kolkata
WEST BENGAL
700064
India |
| Phone |
8420244544 |
| Fax |
|
| Email |
drrajeevraman@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajeev Raman |
| Designation |
Consultant Orthopaedic |
| Affiliation |
Joint & Bone Care Hospital |
| Address |
DD-35, 2nd Avenue, DD Block,
Salt Lake City Sector 1
Kolkata
WEST BENGAL
700064
India |
| Phone |
8420244544 |
| Fax |
|
| Email |
drrajeevraman@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indchemie Health Specialties Pvt Ltd
510, Shah & Nahar Industrial Estate,
Dr Elijah Moses Rd, Worli Naka,
Mumbai, Maharashtra, 400018 - India |
|
|
Primary Sponsor
|
| Name |
Indchemie Health Specialties Pvt Ltd |
| Address |
510 Shah and Nahar Industrial Estate, Dr Elijah Moses Road Worli Naka,Mumbai Maharashtra |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajeev Raman |
Joint & Bone Care Hospital |
Department of Orthopaedic Room No 1 DD-35 2nd Avenue DD Block
Salt Lake City Sector 1 Kolkata west Bengal, 700064
Kolkata
WEST BENGAL |
8420244544
drrajeevraman@gmail.com |
| Dr Mahesh Patil |
Suman Accident Clinic |
Department of Orthopedic, Room No 1, Ganga Complex Phase-A, Above Axis Bank ATM and Bafana Hardware, Opposite Business Bay and Neeta Park Society, Old Airport Road, Yerwada, Pune, 411006
Pune
MAHARASHTRA |
9822000326
drmaheshpatil.22@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Central Independent Ethics Committee |
Approved |
| Horizon Life Line PVT.LTD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fracture |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
Its an Observational Study |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Suffered a fracture- Simple fracture/ Open fractures/ Comminuted fracture
Administered CQ for management of fracture (only/in combination with other medication)
Provide consent to participate
|
|
| ExclusionCriteria |
| Details |
Do not provide consent
Patients with hypercalcemia, Paget disease, malignant tumors, joint dysfunction, and significant polytrauma.
Patients on steroid therapy or immunosuppressants and any other medications affecting bone metabolism.
Pregnant or lactating patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effectiveness of oral nutritional supplement containing Cissus Quadrangularis in fracture healing as assessed by
Radiological assessment
Pain
Swelling
Sleep disturbances. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety and tolerability of oral nutritional supplement containing Cissus Quadrangularis by monitoring complaints and adverse events. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
15/05/2026 |
| 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="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
|
This study will use a prospective observational real world study recruiting people with fractures who come for routine care at the study sites and who are treated with Cissus Quadrangularis. They will be recruited for this study after completion of the informed consent process. The recruitment period is for two months. The study is planned as a follow up with a period of four months patient tracking period after recruitment. The primary objective is to evaluate the effectiveness of oral nutritional supplement containing Cissus Quadrangularis in fracture healing as assessed by radiological assessment, pain, swelling and sleep disturbances. |