FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/090554 [Registered on: 09/07/2025] Trial Registered Prospectively
Last Modified On: 08/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A study on medicated oil enema and medicated capsule in reducing knee joint pain. 
Scientific Title of Study   An open label single arm clinical study on combined effect of Prasarini Taila Matra Basti and Parasarini Capsule in Janusandhigatavata (Osteo-Arthritis of Knee) 
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 Arulkar 
Designation  PG Scholar 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  Department of Kayachikitsa Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan-573201 Karnataka India

Hassan
KARNATAKA
573201
India 
Phone  9527425350  
Fax    
Email  arulkaraditya@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Totad Mutappa 
Designation  Professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  Department of Kayachikitsa Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan-573201 Karnataka India

Hassan
KARNATAKA
573201
India 
Phone  9886924949  
Fax    
Email  totadmv225@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vasantha B 
Designation  Associate Professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  Department of Kayachikitsa Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan-573201 Karnataka India

Hassan
KARNATAKA
573201
India 
Phone  9886213224  
Fax    
Email  drvasantha225@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan-573201 Karnataka India  
 
Primary Sponsor  
Name  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan Karnataka India 573201 
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 
Dr Aditya Arulkar  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital  OPD and IPD under all the departments of Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital, Thanniruhalla, Hassan 573201 Hassan KARNATAKA India
Hassan
KARNATAKA 		 9527425350

arulkaraditya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Prasarini Capsule, Reference: Ayurvedic Pharmacopoeia Of India, Volume-one, Part-Two; pg-139, pg-140, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 24 Days, anupAna/sahapAna: Yes(details: Luke Warm Water), Additional Information: -
2Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Sushruta Samhita, Procedure details: Matrabasti Karma: Purvakarma: Sthanika abhyanga with Tila Taila and Nadi Sveda will be done on the lower abdomen, back and thighs of the patient. Pradhana karma: Patient will be made to lie in the left lateral position by keeping left leg straight and right leg flexed at the knee joint. Anal orifice will be anointed by using cotton swab dipped in Tila taila and 70 ml of prasarini taila will be administered using rubber catheter attached to enema syringe. Paschat karma: Patient will be advised to turn to supine position and lie down for 5 minutes. Basti retention time will be noted.)
(1) Medicine Name: Prasarini taila, Reference: Bhavaprakasha chikitsaprakarana 24/37, Route: Rectal, Dosage Form: Taila, Dose: 70(ml), Frequency: od, Duration: 8 Days
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Subjects with Radiologic changes in knee x-ray (Kellgren`s Lawrence index Grade1 and Grade2).
2. Subjects fit for basti.
3. Subjects who are willing to participate and sign the informed consent
 
 
ExclusionCriteria 
Details  1. Known cases of gouty arthritis, Rheumatoid arthritis, Psoriatic arthritis.
2. Known cases of fracture of knee joint.
3. Known cases of uncontrolled Hypertension and Diabetes mellitus.
4. Pregnant woman and lactating mother.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in signs and symptoms of Janusandhigatavata (osteo-arthritis of knee) like
1. Sandhi shula (Visual Analogue Scale for pain -VAS)
2. Vatpurndruti sparsh shoth (Swelling)
3. Prasarana akunchana savedana (Range of Motion – Goniometer)
4. Sandhi atopa (Crepitus)
5. Ritchie articular index for assessment of tenderness
6. WOMAC- Index for Osteoarthritis
 		 24 Days 
 
Secondary Outcome  
Outcome  TimePoints 
To improve Quality of Life  24days 
 
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 2 
Date of First Enrollment (India)   25/07/2025 
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="2"
Months="0"
Days="0" 
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  

Sandhigata vata is one among Vatavyadhis. Janu sandhigata vata is presented with symptoms like Vatapoornadruti Sparsha, Shotha, Shoola on Prasarana and Akunchana at Janu sandhi.

Janu sandhigata vata has the similar features of Osteoarthritis, which is the most common type of arthritis occurring in weight bearing joints like hip and knee. Main presenting symptoms are pain and functional restriction. When it occurs in knee, pain is localized to anterior or medial aspect of knee which worsens on going up and down stairs. The prevalence of osteoarthritis rises progressively with age and it has been estimated that 45% of all people develop osteoarthritis during their life. With 6% incidence of age >30 years and 12% incidence >60 years.

Charaka has mentioned Basti as Ardha chikitsa. Matra basti is Balya, Brumhana and Vatahara. Prasarini taila is mentioned in Bhavaparakash possess Vatahara, Balya and Rasayana properties which helps in relieving the symptoms of the Sandhigata vata.

Prasarini mentioned in Ayurvedic Pharmacopeia of India has Tikta Rasa, Katu vipak, Ushna veerya, Guru and Sara properties. Prasarini pacifies Vata because of its Ushna veerya, Guru and Sara properties. Prasarini capsule will be administered orally.

Hence, this study is taken to evaluate combined effect of Prasarini capsule and Prasarini taila in janusandhigata vata.

 
Close