| CTRI Number |
CTRI/2024/04/066536 [Registered on: 30/04/2024] Trial Registered Prospectively |
| Last Modified On: |
23/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Evaluate the efficacy of Rasnadi Gutika along with Chandrakala lepa in Sandhigata Vata (Janu sandhi)w.s.r.to Osteoarthritis (knee joint) |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Comparative Efficacy of Rasnadi Gutika along Chandrakala Lepa with Intra-articular Methylprednisolone acetate Infiltration in Sandhigata Vata(Janu sandhi)w.s.r.to Osteoarthritis(Knee joint) |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Anil Kumar Sharma |
| Designation |
Professor |
| Affiliation |
R.G.G.P.G.Ayurvedic college and hospital Paprola. |
| Address |
Room no.206 of shalya tantra department anatomy block of qR.G.G.P.G.Ayurvedic college and hospital Paprola V.P.O.Paprola teh Baijnath distt Kangra Himachal Pradesh 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9805056393 |
| Fax |
|
| Email |
dranilpaprola@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Anil Kumar Sharma |
| Designation |
Professor |
| Affiliation |
R.G.G.P.G.Ayurvedic college and hospital Paprola. |
| Address |
Room no.206 of shalya tantra department anatomy block of R.G.G.P.G.Ayurvedic college and hospital Paprola V.P.O.Paprola teh Baijnath distt Kangra Himachal Pradesh 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9805056393 |
| Fax |
|
| Email |
dranilpaprola@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shiwani kapoor |
| Designation |
PG SCHOLAR |
| Affiliation |
R.G.G.P.G.Ayurvedic college and hospital Paprola |
| Address |
R.G.G.P.G.Ayurvedic college and hospital Paprola teh Baijnath distt Kangra Himachal Pradesh 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8219985740 |
| Fax |
|
| Email |
shiwanikapoor07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak pharmacy RGGPG ayurvedic college and hospital paprola H.P ,Baijnath pharmacy ,paprola distt kangra H.P.,Jogindernagar pharmacy distt Mandi H.P. |
|
|
Primary Sponsor
|
| Name |
Principal RGGPGAyurvedic college and hospital Paprola |
| Address |
Rajiv Gandhi Goverment Post Graduate Ayurvedic college and Hospital Paprola teh. Baijnath distt Kangra H.P.176115 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Prof Anil kumar sharma |
Room no.206 of shalya tantra anatomy block R.G.G.P.G.Ayurvedic college and hospital Paprola teh baijnath distt kangra H.P.176115 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shiwani kapoor |
R.G.G.P.G.Ayurvedic college and hospital Paprola H.P. |
OPD/IPD of Shalya tantra department R.G.G.P.G.Ayurvedic college and hospital Paprola teh baijnath distt kangra H.P.176115
Kangra
HIMACHAL PRADESH |
8219985740
shiwanikapoor07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE HUMAN |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rasnadi gutika, Reference: AFI vol.3, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: Lukewarm), Additional Information: 2 tablets (1 gm) 500 mg each twice a day after food with lukewarm water(2) Medicine Name: Chandrakala lepa, Reference: AFI vol.3, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: No, Additional Information: Lepa will be applied according to affected surface area of thickness 4 mm till it dry twice a day. | | 2 | Comparator Arm (Non Ayurveda) | | - | Intra-articular methylprednisolone acetate infiltration | 40 mg methylprednisolone acetate with 1ml of 2% lignocaine hydrochloride infiltrated in affected knee joint by lateralpatello femoral approach.1 sitting mandatory and 2nd repeat after 21 days if needed. |
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients fulfilling the diagnostic criteria of OA recommended by American college of Rheumatology.
2)Patients with following radiological findings-definite osteophytes and normal joint space or moderate osteophytes and joint space reduction.
3)Patienys willing for trial. |
|
| ExclusionCriteria |
| Details |
1)Patients having history of trauma,any previous surgery in target knee,knee infection.
2)Patients with systemic disorders
3)ICTC and HBsAg psoitive patients
4)Patients not willing for trial. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in WOMAC total score (at time of baseline and at end of the treatment) |
Total 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in WOMAC stiffness domain score.
Change in WOMAC physical function domain.
Changes in analgesic burden in comparison to Baseline(No.of times of use of conventional analgesic drug)
Assesment of change in clinical parameters(on 0,14,28,42 and 56th day) |
Total 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
12/05/2024 |
| 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="2"
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
|
The trial is in the early phase and is not yet started.the present study the drugs Rasnadi Gutika (Ref.AFI,part3,page111)contains Rasna,Guggulu,Sarpi.according to Ayurveda ,Rasna is a well known drug for vatashamana aswell as have anti-inflammatory,analgesic,antioxidant effect.Guggulu is also vatahara,shoolahara.Sarpi is vatashamaka and brumhaniya. Chandrakala lepa (Ref-AFI,part3,page225)contains Madhuchhista,Sveta Maricha,Coconut oil and Karpoora.Madhuchhista and Coconut oil being snigdha in nature decreases rukshata in joints.Sveta Maricha and karpoora are shoolanashaka and effective in Sandhigata vata. Therefore both above drugs are taken into specific disease condition for the hypothesis that to act effectively for the proper samprapti vighatana by alleviating vata and shoola which are main complaints of diseases. |