| CTRI Number |
CTRI/2025/05/086288 [Registered on: 05/05/2025] Trial Registered Prospectively |
| Last Modified On: |
02/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of Haridradi taila janubasti in knee osteoarthritis. |
|
Scientific Title of Study
|
A randomised controlled clinical trial to evaluate the efficacy of Haridradi taila janubasti in Janusandhigata vata 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 Neha Mukund Bagul |
| Designation |
Post graduate student |
| Affiliation |
SMBT Ayurved College and Hospital Dhamangaon Nasik |
| Address |
OPD no 19, Department of Panchakarma ,SMBT ayurved college and hospital,Dhamangaon , Igatpuri,Nasik 422403
Maharashtra
India
SMBT ayurved college and hospital,Dhamangaon , Igatpuri,Nasik 422403
Maharashtra
India
Nashik
MAHARASHTRA
422403
India |
| Phone |
9209295475 |
| Fax |
|
| Email |
bagulneha2599@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chaitali Tarwate |
| Designation |
Associate professor in department of panchakarma |
| Affiliation |
SMBT Ayurved College and Hospital Dhamangaon Nasik |
| Address |
OPD no 19, Department of Panchakarma ,SMBT ayurved college and hospital,Dhamangaon , Igatpuri,Nasik 422403
Maharashtra
India
SMBT ayurved college and hospital,Dhamangaon , Igatpuri,Nasik 422403
Maharashtra
India
Nashik
MAHARASHTRA
422403
India |
| Phone |
8805694776 |
| Fax |
|
| Email |
chaitalidhamane179@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Mukund Bagul |
| Designation |
Post graduate student |
| Affiliation |
SMBT Ayurved College and Hospital Dhamangaon Nasik |
| Address |
OPD no 19, Department of Panchakarma ,SMBT ayurved college and hospital,Dhamangaon , Igatpuri,Nasik 422403
Maharashtra
India
SMBT ayurved college and hospital,Dhamangaon , Igatpuri,Nasik 422403
Maharashtra
India
Nashik
MAHARASHTRA
422403
India |
| Phone |
9209295475 |
| Fax |
|
| Email |
bagulneha2599@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Panchakarma, SMBT ayurved college and hospital, Dhamangaon,Igatpuri,Nasik 422403 |
|
|
Primary Sponsor
|
| Name |
Dr Neha Mukund Bagul |
| Address |
OPD no 19 ,Department of Panchakarma ,SMBT Ayurved college and hospital ,Dhamangaon ,Igatpuri, Nasik 422403 |
| Type of Sponsor |
Other [Self ] |
|
|
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 Neha Mukund Bagul |
SMBT Ayurved college and hospital |
OPD no 19 ,Department of Panchakarma, SMBT Ayurved college and hospital ,Dhamangaon ,Igatpuri ,Nasik 422403
Nashik
MAHARASHTRA |
9209295475
bagulneha2599@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMBT Ayurved college and hospital, Dhamangaon, Igatpuri, Nasik 422403 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | jAnu-bastiH, जानु-बस्तिः | (Procedure Reference: Panchakarma Illustrated , Procedure details: Nirgundi Taila Janubasti 100 ml for 30 mins for 7 days.)
(1) Medicine Name: Nirgundi Taila , Reference: Charak Chikitsa , Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 07 Days | | 2 | Intervention Arm | Procedure | - | jAnu-bastiH, जानु-बस्तिः | (Procedure Reference: Panchakarma Illustrated , Procedure details: Haridradi Taila Janubasti 100 ml for 30 mins for 7 days.)
(1) Medicine Name: Haridradi Taila , Reference: Vaidyamanorama , Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 07 Days |
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient aged between 45-80 years irrespective of gender and religion
2)Persistent knee joint pain which worsens with use and morning stiffness present which lasts not more than 2 hours. 3)Patients presenting any 2 or more classical signs and symptoms ofJanusandhigata vata that is Janu Sandhishool,Shotha, Sphutana, Sparshasahavta, Sthambhata, Aakunchana Prasarana vedana. |
|
| ExclusionCriteria |
| Details |
1)Patient with K/C/O HIV, TB,DM, neurological disorders,any skindiseases, severe present injury ,fractures or dislocation,bone tumours of knee joint
2)Patients who have taken corticosteriodal injections before 3 months of trial
3)Patients who have metallic implant in knee joint or with TKR
4)Patients with anatomical defect and who needs surgical intervention. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1)To access the effect of Haridradi taila Janubasti for 7 days in signs and symptoms of Janusandhigatavata by comparison of the score of clinical evaluation. |
0th,7th and 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Where the trial group stands in comparison to control group in reduction of signs and symptoms of janusandhigata vata |
18 months |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
16/05/2025 |
| 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) |
Open to Recruitment |
|
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 population based study from India shows prevalence of Janusandhigata vata is 15%. It is one of the disease which is painful and affects normal routine of life.So there is a need to find an alternative solution of this problem .Present study of randomized controlled trial will be carried out to study the efficacy of Haridradi taila janubasti in Janusandhigata vata with special reference to knee osteoarthritis. For present
study subjects between age group 45-80 years will be taken irrespective of the religion ,gender,socioeconomic status. Total sample size taken is 66 and patients will be taken for the study with 33 patients in Group A(trial group) and 33 patients in Group B(control group). Haridradi taila janubasti is taken in group A(trial group) and Nirgundi taila janubasti is taken for Group B(control group). Procedure will be done with external application for 7 days and follow up will be taken on 14th day .All SOP will be followed. All the findings will be entered in case record form .Observations will be drawn before, during and after treatment .Result will be drawn with the help of statistical method.Discussion will be done on the basis of observations. Summary will be drawn .Conclusion will be drawn strictly on basis of statistical analysis and will be unbiased. |