| CTRI Number |
CTRI/2025/08/093133 [Registered on: 18/08/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Testing the Safety of OsteoCaf™ Capsules in Healthy People. |
|
Scientific Title of Study
|
An open-label, single-arm, clinical study to evaluate the safety of standardised leaf extract of Dalbergia sissoo (OsteoCaf TM) Capsules in healthy adult volunteers. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHC/CT/25-26/008 Version: 1.00; dated 23rd June 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ram Mundhe |
| Designation |
Principal Investigator |
| Affiliation |
Gunjkar Multispeciality Hospital |
| Address |
Plot No 315, Sector No 18, Spine Road, Chikhali
-
Pune
MAHARASHTRA
411019
India |
| Phone |
8454859082 |
| Fax |
- |
| Email |
drrammudhe.gunjkarresearch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Siddharth J Modi |
| Designation |
Vice President, Scientific Affairs |
| Affiliation |
Viridis Biopharma Pvt. Ltd |
| Address |
6/10 Jogani Industrial Estate Department of scientific Affairs V. N. Purav Marg Chunabhatti
-
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9309233955 |
| Fax |
- |
| Email |
siddharthmodi@viridisbiopharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Siddharth J Modi |
| Designation |
Vice President, Scientific Affairs |
| Affiliation |
Viridis Biopharma Pvt. Ltd |
| Address |
6/10 Jogani Industrial Estate Department of scientific Affairs, V. N. Purav Marg Chunabhatti
-
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9309233955 |
| Fax |
- |
| Email |
siddharthmodi@viridisbiopharma.com |
|
|
Source of Monetary or Material Support
|
| Phytoveda Pvt. Ltd.6/10 jogani Industrial Complex.N purav Marg, chunabhatti, Mumbai 400022, India |
|
|
Primary Sponsor
|
| Name |
PhytoVeda Pvt. Ltd. |
| Address |
6/10, Jogani Industrial Estate, V. N. Purav Marg, Chunabhatti, Mumbai-400022, India |
| Type of Sponsor |
Other [Private Company] |
|
|
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 Ram Mundhe |
Gunjkar Multispeciality Hospital |
Plot No 315, Sector No 18, OPD 2 Spine Road, Chikhali,Shivtej nagar
-
Pune
MAHARASHTRA |
08454859082
-
drrammudhe.gunjkarresearch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sangvi Multispecialty Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Adults |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
- |
| Intervention |
OsteoCaf TM Capsule |
300 mg capsule, orally twice a day once in the morning after
breakfast and once in the evening after dinner |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy male and female human participants aged between 18 and 65 years (both inclusive)
2.Participants with a BMI between 18.50-30.00 kg/m2
3.Participants in normal physiological health as determined by personal medical
history, clinical examination including vital signs and clinically acceptable
results of laboratory examinations (including serological tests)
4.Participants having a normal or clinically not significant 12-lead electrocardiogram (ECG) recording
5.Participants having a normal or clinically not significant chest X-ray (PA view)
6.Willingness to adhere to dietary restrictions and avoid other supplements or medications during the study period
7.Participant able to communicate effectively and willing to provide written informed consent
8.Participants willing to adhere to the protocol requirements as evidenced by written informed consent approved by the ethics committee
9.Availability of volunteers for the entire study duration. |
|
| ExclusionCriteria |
| Details |
1.Known hypersensitivity to Dalbergia sissoo extract or related product or any
component of this intervention
2.Clinically significant medical condition, such as but not limited to cardiovascular, neurological psychiatric, pulmonary, renal, immunological,
endocrine, or haematological abnormalities;
3. Evidence of significant clinical abnormalities detected during the screening procedure determined by the investigator;
4.History of any acute/chronic disorders
5.History of chronic medication within the past 6 weeks
6.history of hypersensitivity to any medication
7.History of use of drugs known to affect CNS performance
8.Regular smokers who smoke more than 9 cigarettes daily or have difficulty in abstaining from smoking during the study duration
9.History of drug dependence or chronic alcohol use associated with or without altered hepatic functions, use of any microsomal enzyme modifying drugs within 30 days, and/or systemic medication including OTC preparation 14 days before day 1 of the study
10.Positive screening test result for any one or more of the following: HIV, Hepatitis
B, Hepatitis C, and VDRL
11.Participation in any clinical trial within 3 months preceding day 1 of the study
12.Males and females of childbearing potential unwilling to employ an appropriate and reliable method of contraception, women with anticipated
pregnancy/pregnant/lactating/ using oral contraceptives
13.Any other condition that, in the opinion of the investigator, could jeopardise the safety of the participant or affect the integrity of the study data |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess the safety of the intervention as measured by:
i. Incidence of adverse events (AEs) and serious adverse events (SAEs)
ii. Physical examination results
iii. Incidence of abnormal vital signs. |
at baseline, day 30, day 60, and day 90 (end of the study) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the safety of the intervention as measured by
i. Changes in biomarkers- Complete Blood Count (CBC), Liver Function test (LFT) and Renal Function Test (RFT), Thyroid Function Test, Lipid profile, Serum electrolytes, and Urine analysis, etc.
ii. Changes in serum ferritin, serum iron, total iron binding capacity, Vitamin B12, estrogen (females), progesterone (females), and testosterone (males)
2. Treatment compliance & tolerability |
1.
i.at screening, day 30, day 60, and day 90
ii. at screening and day 90
2. at day 30, day 60, and day 90 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
18/08/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Osteoporosis, fractures, and other metabolic bone disorders represent a significant and growing
public health concern, particularly among ageing populations and postmenopausal women.
Current pharmacological treatments, while effective, often carry adverse effects or limitations
in long-term use, highlighting the need for safer, well-tolerated alternatives. Dalbergia sissoo
(Indian Rosewood) has been traditionally used in Ayurvedic medicine for managing
musculoskeletal conditions such as joint pain, inflammation, and bone-related ailments.
Preclinical studies have demonstrated that standardised extracts from Dalbergia sissoo,
particularly its leaf and heartwood, possess osteogenic, anti-inflammatory, and antioxidant
properties, promoting fracture healing and preventing bone loss through osteoblast stimulation
and improved bone microarchitecture.
OsteoCaf™ is a standardised extract derived from Dalbergia sissoo, formulated specifically to
support bone health and aid in the management of conditions like osteoporosis and fracture
recovery. While clinical safety data in humans remains limited. Establishing human safety
through a clinical study is a critical first step before exploring efficacy in at-risk or diseased
populations. This open-label, single-arm study is thus designed to evaluate the safety of
OsteoCaf™ capsules in healthy adult volunteers, generating essential data to support its future
clinical development as a safe botanical intervention for bone health. |