| CTRI Number |
CTRI/2023/10/059307 [Registered on: 30/10/2023] Trial Registered Prospectively |
| Last Modified On: |
23/10/2023 |
| 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 Effects of Two Ayurvedic Kashaya Formulations, Marichadi Kashaya and Rasnapanchaka Kashaya in Patients of Janusandhigata Vata(Knee Joint Osteoarthritis) |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study of
Marichadi Kwatha in the Management of
Janusandhigata Vata
|
| 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 Shabna Rani S R |
| Designation |
PG Scholar |
| Affiliation |
Alvas A yurveda Medical College and Hospital |
| Address |
Alvas Ayurveda Medical College and Hospital,Vidyagiri, Moodbidri
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9074480115 |
| Fax |
|
| Email |
drshabnasajeed@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surekha Pai |
| Designation |
MD (Ayurveda) |
| Affiliation |
Alvas Ayurveda Medical College and Hospital |
| Address |
Alvas Ayurveda Medical College,Vidyagiri ,Moodbidri
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8921385332 |
| Fax |
|
| Email |
drsurpai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shabna Rani S R |
| Designation |
PG Scholar |
| Affiliation |
Alvas A yurveda Medical College and Hospital |
| Address |
Alvas Ayurveda Medical College,Vidyagiri ,Moodbidri
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9074480115 |
| Fax |
|
| Email |
drshabnasajeed@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodbidri |
|
|
Primary Sponsor
|
| Name |
Dr Shabna Rani S R |
| Address |
Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodabidri |
| 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 Shabna Rani S R |
Alvas Ayurveda Medical College |
PG Studies in the Department of Kayachikitsa, Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodbidri, D.K.Karnataka, Karnataka
Dakshina Kannada
KARNATAKA |
9074480115
drshabnasajeed@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Clinical Ethics Committee Alvas Ayurveda Medical College, Vidyagiri, Moodabidri,India |
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: Marichadi Kwatha, Reference: Gadanigraha Vol 2 ,chapter19 , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -3ml lukewarm tilataila), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Rasnapanchaka kwatha, Reference: Chakradatta ,25th chapter, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -3ml lukewarm tilataila), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with classical symptoms of Janusandhigata Vata like Sandhi Shoola, Sandhi Atopa, Prasarana Akunchana Vedana (unilateral or bilateral ) with or without Sandhi Sthamba and Sandhi Shopha.
2.Patient with age group of 30 -70 year old of either gender.
3.Patients who are willing to participate in study and sign in the consent form.
|
|
| ExclusionCriteria |
| Details |
1.Patients suffering from diseases like Vatarakta and Amavata.
2.Patient with deformities like Genu varum and Genu valgum.
3.Secondary Osteoarthritis of Knee.
4.Patient who requires surgical interventions.
5.Pregnant women and Lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of the treatment will be done based on detailed case proforma,by adopting standard scoring methods of subjective parameters such as janusandhi shoola, janusandhi sthambha, tenderness, VISUAL Analogue Scale and WOMAC Osteoarthritis Index. |
45 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Objective parameters like Janu sandhi Shotha, Janu Sandhi Atopa, Range of movement will measure by using goniometer |
45 Days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
05/11/2023 |
| 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="2"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 is a randomized,single blind,parallel group ,actively controlled clinical study with comparative standard drug- Rasnapanchaka kwatha and interventional drug- Marichadi kwatha with the dosage 25ml (total 50ml per day )kwatha along with 3ml of luke warm tila taila(6ml per day ) as anupana after food twice daily.This study is conducting on two groups of( 30 patients in each group) patients of Janusandhigata Vata (Osteoarthritis of knee joint )belongs to age of 30 yrs to 70 yrs who gives written and verbal consent for undergoing clinical study. Interventional period of this study is 30 days .Assessment will be done on before treatment ,16 th day, 31st day and 46th day |