| CTRI Number |
CTRI/2025/02/080022 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effectof two drugs Aabhadi Churna Vati and Lakshadi Guggul in patients with sandhivata |
|
Scientific Title of Study
|
A randomized controlled clinical study to evaluate the efficacy of Aabhadi Churna Vati in the management of Dhatukshayajanya Janu Sandhigatvat in age group 40 to 70 years |
| 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 Aditya Dilip Kale |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurved and Research Centre |
| Address |
PDEAs College of Ayurveda and Research centre,third floor
kayachikitsa Department Nigdi pradhikaran,Pune.
Pune
MAHARASHTRA
411044
INDIA
Pune
MAHARASHTRA
411044
India |
| Phone |
9975797728 |
| Fax |
|
| Email |
adityakale357@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhishek Girish Taksale |
| Designation |
Associate Professor |
| Affiliation |
PDEAs College of Ayurved and Research Centre |
| Address |
PDEAs College of Ayurveda and Research centre,third floor
kayachikitsa Department Nigdi pradhikaran,Pune.
Pune
MAHARASHTRA
411044
INDIA
Pune
MAHARASHTRA
411044
India |
| Phone |
9011061293 |
| Fax |
|
| Email |
taksaleabhishek@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aditya Dilip Kale |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurved and Research Centre |
| Address |
PDEAs College of Ayurveda and Research centre,third floor
kayachikitsa Department Nigdi pradhikaran,Pune.
Pune
MAHARASHTRA
411044
INDIA
Pune
MAHARASHTRA
411044
India |
| Phone |
9975797728 |
| Fax |
|
| Email |
adityakale357@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research centre pradhikaran Nigdi pune |
|
|
Primary Sponsor
|
| Name |
PDEAs College of Ayurved and Research Centre pradhikaran Nigdi pune |
| Address |
PDEAs College of Ayurved and Research Centre pradhikaran Nigdi pune 411044 |
| 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 Aditya Dilip Kale |
PDEAs Ayurved Rugnalaya and Multi-speciality Hospital |
Sector27,
Kayachikitsa
Department, Room no
117 Nigdi Pradhikaran
Pune.411044
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
9975797728
adityakale357@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 | Drug | Classical | | (1) Medicine Name: Lakshadi Guggul, Reference: Bhaishajya ratnavali bhagnarogachikitsa, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -koshna jal), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Aabhadi Churna Vati, Reference: Yogratnakar Vata Vyadhi, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Koshna Jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having classical sign and symptoms of Dhatukshayjanya Janusandhigatvat (If any 3 present)
2. Janusandhi Shula (Pain)
3. Janusandhi Shotha (Swelling)
4.Janusandhi Graha(stiffness)
5.Janusandhi Sphutana (Crepitus)
6. Patients of either sex aged between 40 to 70 years
7. X-Ray of knee joint suggestive of degenerative changes |
|
| ExclusionCriteria |
| Details |
1.Major systemic disorders - cancer, cirrhosis of liver,kidney failure
2.Patients with known case of Rheumatoid arthritis, Psoriatic arthritis,Gouty arthritis,Systemic lupus erythematous,Bone tuberculosis,Previous knee surgeries,knee implants
3. Known case of Fracture of knee joint.
4. Known case of direct and indirect infection of knee joint
5.history of any surgical procedure of knee joint |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare effectiveness of Aabhadi Churna vati 500mg at vyanodan kala with koshnajala for 60 days and Lakshadi Guggul 500mg at vyanodan kala with koshnajala for 60 days in the management of Dhatukshayajanya Janu Sandhigatvat |
60 days with follow up 15th 30th 45th 60th |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the adverse effect if any |
60 days with follow up 15th 30th 45th 60th |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
17/02/2025 |
| 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="0"
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
|
Ayurveda has described about the pathogenesis and treatment of various disorders.Dhatukshayajanya Sandhigatvata in Janu sandhi is one of such chronic degenerative inflammatory disease ehicha has a great impact on quality of life of an individual. Vata dosha plays main role in this disease The pathogenesis undergoing of this disease are attributing of the aberration of vata and kaphadoaha affecting the asthi, sandhi, mamsa and snayu. Aabhadi Churna vati is mentioned effective in Sandhigatvata of Janusandhi. |