| CTRI Number |
CTRI/2025/12/099044 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
12/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A Study To Test How Well Pirandai Cissus Quadrangularis Gel Works In Reducing Bone Pain Caused By Arthritis |
|
Scientific Title of Study
|
A Randomized Controlled Trial on the Effectiveness of Cissus quadrangularis (Pirandai) Topical Gel for Managing Arthritis-Related Bone
|
| 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 Ragasrimathi R G |
| Designation |
Post Graduate |
| Affiliation |
Saveetha medical College and hospital |
| Address |
Saveetha medical College and hospital,SIMATS UNIVERSITY ,Thandalam campus.
Saveetha medical College and hospital,SIMATS UNIVERSITY ,Thandalam campus.
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
8056961297 |
| Fax |
|
| Email |
ragaisai10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shiny Chrism Queen Nesan |
| Designation |
Associate Professor |
| Affiliation |
Saveetha medical College and hospital |
| Address |
Saveetha medical College and hospital,SIMATS UNIVERSITY ,Thandalam campus.
Saveetha medical College and hospital,SIMATS UNIVERSITY ,Thandalam campus.
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
8056961297 |
| Fax |
|
| Email |
shinynesan75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ragasrimathi R G |
| Designation |
Post Graduate |
| Affiliation |
Saveetha medical College and hospital |
| Address |
Saveetha medical College and hospital,SIMATS UNIVERSITY ,Thandalam campus.
Saveetha medical College and hospital,SIMATS UNIVERSITY ,Thandalam campus.
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
8056961297 |
| Fax |
|
| Email |
ragaisai10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha medical College and hospital,SIMATS UNIVERSITY ,Thandalam campus.602105.
|
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [] |
|
|
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 RAGASRIMATHI R G |
Saveetha Rural Health Center |
SAVEETHA RURAL HEALTH CENTER MAPPEDU,KILACHERI,THIRUVALLUR 631402.
Thiruvallur
TAMIL NADU |
8056961297
ragaisai10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMCH-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Topical gel pain using extract of pirandai for relieving arthritis related bone pain |
topical gel with Cissus quadrangularis extract applied topically data collected 2nd and 4th week for 3 months |
| Comparator Agent |
Topical pain releiving gel available in the market |
compare with the available topical gel in the standrad market for arthitis related pain |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Adults more than 40 years of age
Diagnosed with Arthitis for more than 3 months
Willingness to participate with informed consent |
|
| ExclusionCriteria |
| Details |
Should not be on Oral corticosteriod
tropical and intramuscuoar corticosteriods respectively |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain scores using the Visual Analogue Scale (VAS) at baseline, 2 weeks, and 4 weeks. |
Every 2nd weeks, and 4 th weeks For three months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in joint function assessed by WOMAC score
Patient reported improvement & satisfaction
Adverse events during the trial
|
3 MONTH |
|
|
Target Sample Size
|
Total Sample Size="93"
Sample Size from India="93"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
24/12/2025 |
| 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="3"
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
|
14. Objectives of the project :
15. Expected duration of the project : 1 year
16. Benefit of the research project :
This study evaluates the
effectiveness of a Cissus quadrangularis (Pirandai) herbal infusion
formulated as a topical gel, aiming to offer a scientifically validated,
plant-based therapeutic option within the framework of modern medicine. By
integrating traditional knowledge with clinical evidence, the research has the
potential to introduce a safe, accessible, and locally available remedy into
mainstream arthritis care—especially valuable in settings where long-term
pharmacological treatment may be costly or associated with adverse effects
16.1 To the Participants/patients :
Participants may
experience relief from arthritis-related bone pain through the application of a
natural, non-invasive topical gel.The study promotes awareness of
scientifically supported herbal interventions that can complement conventional
treatment strategies.Reduced dependence on long-term use of oral analgesics or
NSAIDs, potentially minimizing associated side effects
16.2 To the Society/Knowledge :
Contributes to the
scientific integration of traditional herbal remedies into modern,
evidence-based medical practice.Promotes the use of cost-effective and
accessible alternatives for managing chronic joint pain, particularly in
resource-limited settings.
Encourages
interdisciplinary collaboration between traditional medicine and clinical
research.Informs public health initiatives by introducing validated herbal
options that can complement standard arthritis care and reduce reliance on
long-term pharmacological treatments |