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CTRI Number  CTRI/2024/08/072463 [Registered on: 13/08/2024] Trial Registered Prospectively
Last Modified On: 09/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Chandrashoor beeja churna with Chandrashoor beeja lepa in Osteoarthritis of knee. 
Scientific Title of Study   A Study to Evaluate the Combined Efficacy of Chandrashoor Beeja Churna Orally Along with Chandrashoor Beeja Pradeha in Janusandhigata Vata W.S.R. Osteoarthritis of the Knee - an open labelled single arm clinical study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  PRIYA J PANCHAL 
Designation  PG Scholar  
Affiliation  Shree Swaminarayan Ayurvedic College,Kalol 
Address  Department of Kayachikitsa, Shree Swaminarayan Ayurvedic College,Opp.Kalol GIDC,Saij,Ahmedabad-Mehsana Highway,AT&PO,Ta,Saij,Kalol

Gandhinagar
GUJARAT
382725
India 
Phone  9173109729  
Fax    
Email  pjpanchal1999@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Vd Tapankumar M 
Designation  Professor  
Affiliation  Shree Swaminarayan Ayurvedic College,Kalol 
Address  Department of Kayachikitsa, Shree Swaminarayan Ayurvedic College,Opp.Kalol GIDC,Saij,Ahmedabad-Mehsana Highway,AT&PO,Ta,Saij,Kalol

Gandhinagar
GUJARAT
382725
India 
Phone  9924304388  
Fax    
Email  vdtapankumar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vishal Solanki 
Designation  Associate Professor 
Affiliation  Shree Swaminarayan Ayurvedic College,Kalol 
Address  Department of Kayachikitsa, Shree Swaminarayan Ayurvedic College,Opp.Kalol GIDC,Saij,Ahmedabad-Mehsana Highway,AT&PO,Ta,Saij,Kalol

Gandhinagar
GUJARAT
382725
India 
Phone  9558121886  
Fax    
Email  vishal12solanki@gmail.com  
 
Source of Monetary or Material Support  
Shree Swaminarayan Ayurvedic College and Hospital,Ahmedabad-Mehsana Highway,AT&PO.Saij,Ta,Kalol Dist.Gandhinagar-382725 
 
Primary Sponsor  
Name  Shree Swaminarayan Ayurvedic College 
Address  Faculty of Ayurved, Shree Swaminarayan Ayurvedic College, Ahmedabad-Mehsana Highway, AT&PO. Saij, Ta. Kalol, Dist. Gandhinagar- 382725 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrPriya J Panchal  Premswarup Swami Ayurvedic Multispecialty Hospital  OPD-004 Department of Kayachikitsa Premswarup Swami Ayurvedic Multispecialty Ahmedabad-Mehsana Highway,AT&PO.Saij,Ta,Kalol Dist.Gandhinagar-382725 Hospital
Gandhinagar
GUJARAT 		 9173109729

pjpanchal1999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Shree Swaminarayan Ayurvedic College and Hospital, Kalol  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Chandrashoor Beeja Churna , Reference: Bhavpraksha Purvakhanda ch 2, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Dugdha ), Additional Information: -
2Intervention ArmProcedure-pradeha, प्रदेह (Procedure Reference: Su.sutrasthan.ch.18, Procedure details: The freshly dried Chandrashoor is taken in a clean vessel and added with the required small quantity of warm water. The mixture is thoroughly triturated to obtain it in thick paste form, which is used as pradeha for external application.Pradeha is removed soon after drying (different in all patients)from the skin with warm water.)
(1) Medicine Name: Chandrashoor Beeja, Reference: Sodhala Nighantu Ch 2, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 5(g), Frequency: od, Duration: 28 Days
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Vatapurnadrutisparsha shotha (knee joint swelling)
2.Sandhishula (Knee joint pain)
3.Prasaranakuncapravruti savedana (Difficulty in flexion and extension of knee joint)
4.Patients of age ≥40 to ≤70 years.
5.Chronicity less than 2 years
6.Controlled HTN (BP≤150/90), D.M.(RBS ≤140). 
 
ExclusionCriteria 
Details  1.Patients ≤40 years and ≥ 70 years of age.
2.Chronicity of more than 2 years
3.Visible OA deformity, Ligamental injury
4.Fracture and dislocation of knee
joint
5. Diabetic related myopathy
6.Total Knee Replacement and Advised Knee Replacement
7.K/C/of – RA, Trauma, Gout, Infective arthritis, Psoriatic arthritis, etc
8.Osteoporosis, Osteomyelitis.
9.Uncontrolled HTN & DM
10.Serious systemic illness i.e. CKD, IHD, Metabolic syndrome, etc. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Efficacy of Chandrashoor beeja churna orally along with Chandrashoor
beeja pradeha in janu sandhigata vata (Osteo-Arthrisitis Of Knee). 		 14 days 
 
Secondary Outcome  
Outcome  TimePoints 
To devlop an understanding of Janusandhigata vata based on the principles of Ayurveda.
To develop an understanding of Knee Osteoarthritis according to modern science.
To study the properties & effects of Chandrashoor beeja churna orally along with Chandrashoor beeja pradeha in Janusandhigata vata. 		 28 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/10/2024 
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="1"
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   Janu Sandhigata Vata, commonly known as osteoarthritis of the knee, is a prevalent degenerative joint disorder causing pain, stiffness, and reduced mobility. Ayurvedic medicine offers holistic approaches for managing such conditions, including the use of herbal formulations like Chandrashoor Beeja Churna and Chandrashoor Beeja Pradeha. The Single Arm study enrolled 40 participants with clinically diagnosed osteoarthritis of the knee. Participants were administered Chandrashoor Beeja Churna (10gm per day) orally along with topical application of Chandrashoor Beeja Pradeha for 28 days. The study demonstrated significant improvements in pain relief, joint function, and quality of life among participants. 
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