| CTRI Number |
CTRI/2025/04/084501 [Registered on: 09/04/2025] Trial Registered Prospectively |
| Last Modified On: |
09/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study to Test the Effect of Lakshadi Guggulu with Physiotherapy in People with Knee Joint Pain (Osteoarthritis) |
|
Scientific Title of Study
|
Randomized Double Blind Placebo Controlled Study of Lakshadi Guggulu along with Physiotherapy in Sandhigatavata with special reference to Knee Osteoarthritis |
| 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 Mansi Deore |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved and Research |
| Address |
Parul Institute of Ayurved and Research Department of Kayachikitsa 3rd floor room no. Parul University, Ishwarpura, Limda,391760,Vadodara,Gujrat,
India
Vadodara
GUJARAT
391760
India |
| Phone |
9588602572 |
| Fax |
|
| Email |
mansideore66@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaishali Deshpande |
| Designation |
Guide,HOD,Professor |
| Affiliation |
Parul Institute of Ayurved and Research |
| Address |
Parul Institute of Ayurved and Research Department of Kayachikitsa 3rd floor room no. Parul University, Ishwarpura, Limda,391760,Vadodara,Gujrat,
Vadodara
GUJARAT
391760
India |
| Phone |
9096082950 |
| Fax |
|
| Email |
dr.vaishalid@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mansi Deore |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved and Research |
| Address |
Parul Institute of Ayurved and Research Department of Kayachikitsa 3rd floor room no. Parul University, Ishwarpura, Limda,391760,Vadodara,Gujrat,
Vadodara
GUJARAT
391760
India |
| Phone |
9588602572 |
| Fax |
|
| Email |
mansideore66@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Ayurved and research Department of kayachikitsa 3rd floor room no Parul university,Ishwarpura, Limda,391760,Vadodara,Gujarat,India |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayueved and Research |
| Address |
Parul Institute of Ayurved and research Department of kayachikitsa 3rd floor room no Parul university,Ishwarpura, Limda,391760,Vadodara,Gujarat,India |
| Type of Sponsor |
Private medical college |
|
|
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 Mansi Deore |
Khemdas Hospital |
OPD No. 8 Ground Floor Department of Kayachikitsa Khemdas Hospital Ishwarpura P.O Limda Waghodiya-391760 Vadodara Gujrat India
Vadodara
GUJARAT |
9588602572
mansideore66@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,PIAR-IECHR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Lakshadi Guggulu, Reference: Bhaishajya Ratnavali 49/13-14, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: -Additionally physiotherapy will be given | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Placebo, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: -Additionally physiotherapy will be given |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients showing symptoms of sandhi Gata Vata of Janu Sandhi
2. Patient having baseline knee joint pain more than 40 mm on Visual Analogue Scale (VAS) either at rest or on weight bearing activities (e.g. walking, standing, climbing staircase) during the preceding 24 hours
3. Morning stiffness less than 30 min.
4. Patients willing to follow up.
5. Patients willing to give written informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Patients with known case of gout, rheumatoid arthritis, psoriatic arthritis, septic arthritis, and congenital joint anomalies.
2.Patients with history of rickets, osteomalacia.
3.Participants with history of auto-immune disease, uncontrolled hypertension, chronic severe respiratory disease History of life threatening cardiovascular and /or neurological event in the past one year
4.Morning stiffness more than 30 min.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Lakshadi Guggulu with Physiotherapy in comparison with Placebo with Physiotherapy on the basis of subjective parameters like Joint pain, swelling, stiffness, difficulty in movements using VAS (Visual Analog Scale) |
0,15,30,45,60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the effect of Lakshadi Guggulu with physiotherapy versus placebo with physiotherapy on the basis of requirement of rescue medicines in term of dose, frequency and duration in either group from baseline till end of the study.
|
0,15,30,45,60th day |
| To study the effect of Lakshadi Guggulu with physiotherapy versus placebo with physiotherapy on the basis of WOMAC total score and subscore. |
0,15,30,45,60th Day |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
02/05/2025 |
| 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="1"
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 aims to evaluate the effectiveness of Lakshadi Guggulu combined with physiotherapy in managing knee osteoarthritis (Sandhigata Vata) compared to a placebo with physiotherapy. The research will involve patients aged 40-70 with symptomatic knee osteoarthritis. The treatment will be assessed using subjective measures like pain, swelling, stiffness, and joint mobility using Visual Analog Scale (VAS) and WOMAC scores. The study design is a randomized double-blind placebo-controlled trial, with 78 participants divided into two groups. The treatment will last 60 days with follow-up assessments at 15, 30, 45, and 60 days. The study will include statistical analysis using SPSS, and ethical clearance will be obtained from the Institutional Ethics Committee. The primary focus is on evaluating the combination of Lakshadi Guggulu and physiotherapy for long-term relief and improving patient quality of life. |