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CTRI Number  CTRI/2022/09/046006 [Registered on: 28/09/2022] Trial Registered Prospectively
Last Modified On: 28/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To know the effect of two varieties of enema pattern with Panchamoolabalasiddha Ksheera in Osteoarthritis  
Scientific Title of Study   “To evaluate the effect of Kashyapokta and Vagbhatokta Kala Basti with Panchamoolabalasiddha Ksheera in Janu Sandhigatavata - A Comparative Clinical Study” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Tejali Rohidas 
Designation  PG Scholar 
Affiliation  Government Ayurveda Medical College Dhanwantari Road Bengaluru-560009 
Address  Second Year PG Scholar Department of Panchakarma Government Ayurveda Medical College Dhawantari Road Bengaluru-560009

Bangalore
KARNATAKA
560009
India 
Phone  9108097076  
Fax    
Email  tejalirohidas@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sangnor Smita Laxmanrao 
Designation  Professor  
Affiliation  Government Ayurveda Medical College Dhanwantari Road Bengaluru-560009 
Address  Professor Department of Panchakarma Government Ayurveda Medical College Dhawantari Road Bengaluru-560009

Bangalore
KARNATAKA
560009
India 
Phone  9035869088  
Fax    
Email  drsmitaghule148@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sangnor Smita Laxmanrao 
Designation  Professor  
Affiliation  Government Ayurveda Medical College Dhanwantari Road Bengaluru-560009 
Address  Professor Department of Panchakarma Government Ayurveda Medical College Dhawantari Road Bengaluru-560009

Bangalore
KARNATAKA
560009
India 
Phone  9035869088  
Fax    
Email  drsmitaghule148@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurvedic Medical College and Hospital,Bangaluru-560009 
 
Primary Sponsor  
Name  DrTejali Chandrakant Rohidas 
Address  Second Year PG Scholars Department of Panchakarma Government Ayurveda Medical College, Dhanwantari Road, Bengaluru-560009 
Type of Sponsor  Other [SELF] 
 
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 Tejali Chandrakant Rohidas  Government Ayurveda Medical and Hospital ,Bengaluru  OPD NO-6,IPd and camps Department of PG Studies in Panchakarma Government Ayurveda Medical college and Hospital, Bengaluru-09
Bangalore
KARNATAKA 
9108097076

tejalirohidas@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government Ayurveda medical college Institutional Ethical committee   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 ArmProcedure-kAla-bastiH, काल-बस्तिः (Procedure Reference: Astanaga Hridaya, Procedure details: Vagbhatokata kala basti (Group -A) Poorva Karma- 1.Deepanapachana with Hingvashtaka choorna 3gm BD with ushna jala until nirama lakshana. 2.Koshthashodhana with Gandharvahastadi taila. 3.Sthanika Abhyanga with Ksheerbala taila followed by Bashpa Sweda. 4.Laghubhojana before Anuvasana prayoga. Pradhana Karma- 1.PanchamoolabalasiddhaKsheera in Kala Basti schedule. 2.Dose:480ml 3.Anuvasana Basti with Guggulu Tiktaka Ghrita. Paschat Karma- 1.After Niruha Basti pratyagamana ushna jala s)
(1) Medicine Name: Panchamoolabalasiddha ksheera, Reference: Gadanigraha,Chakradatta, Route: Rectal, Dosage Form: Ksheerpaka, Dose: 480(ml), Frequency: od, Duration: 5 Days
(2) Medicine Name: Guggulu Tiktaka Ghrita, Reference: Astanga Hridaya , Route: Rectal, Dosage Form: Ghrita, Dose: 60(ml), Frequency: od, Duration: 10 Days
2Comparator ArmProcedure-kAla-bastiH, काल-बस्तिः (Procedure Reference: Kashyapa Samhita, Procedure details: Kashyapokta Kala Basti (Group-B) Poorva Karma- 1.Deepana pachana with Hingvashtaka choorna 3gm BD with ushna jala until nirama lakshana. 2.Koshthashodhana with Gandharvahastadi taila. 3.Sthanika Abhyanga with Ksheerbala taila followed by Bashpa Sweda. 4.Laghu bhojana before Anuvasana prayoga. Pradhana Karma- 1.Panchamoolabalasiddha Ksheera in Kala Basti schedule. 2.Dose:480ml 3.Anuvasana Basti with Guggulu Tiktaka Ghrita 4.Dose: 60ml Paschat Karma- 1.After Niruha Basti pratyagamana u)
(1) Medicine Name: Panchamoolabalasiddhaksheera, Reference: Gadanigraha,Chakradatta, Route: Rectal, Dosage Form: Ksheerpaka, Dose: 480(ml), Frequency: od, Duration: 3 Days
(2) Medicine Name: guggulu Tiktaka Ghrita, Reference: Astanga Hridaya, Route: Rectal, Dosage Form: Ghrita, Dose: 60(ml), Frequency: od, Duration: 12 Days
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Subjects fit for Basti Karma.
2. Subjects diagnosed with Janu
Sandhigatavata.
3. Age-40-70yrs of either sex.
 
 
ExclusionCriteria 
Details  1. Fracture of the knee joint.
2. Subjects with BMI >30.
3. Subjects with secondary OA.
4. Subjects with uncontrolled DM, HTN and
cardiac disease.
5. Malignant condition and congenital
deformity.
6. Pregnant and lactating women.

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Sandhi shoola (pain)
2.Sandhisthabdhata (stiffness)
 
Before treatment on -0th day
After completion of treatment-on 10th day and 12th day.
Follow up on -36th day.

 
 
Secondary Outcome  
Outcome  TimePoints 
1.Sandhishotha (swelling)
2.Crepitus
3.Akunchanaprasaranavedana (Goniometer)
4.WOMAC Scale
5.Waking time 
1.Before treatment on - 0th day.
2.After completion of treatment-10th and 12th day
3.Follow up on-36th day 
 
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)   01/10/2022 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

In Panchakarma, Basti is considered as “Ardhachikitsa” in the management of disease. When Basti is administered, it reaches pakwashaya and removes dosha from all over the body.It is the best treatmentline for Asthyashrayaja vyadhi.As per Acharya Charaka, Basti is mentioned as Vataharanam shrestam.So it is helpful in vatajadiseases like Janu Sandhigatavata where vriddhi in Ruksha guna of vata and kshaya of shleshakakapha produces pain and stiffness of knee joint during movement. All Vatavyadhi requires shodhana along with brumhana line of treatment. Acharya Sushruta has mentioned that 9-11 Anuvasana Basti is required for vata predominant diseases.This is fulfilled by Kala Basti pattern of Acharya Kashyapa and Acharya Vagbhata.Janu Sandhigatavata is vatajavyadhi presented with symptoms of Sandhishoola,vatapurnadrutisparshashotha and prasaranaakunchana vedana.It has symptoms similar to osteoarthritis of knee in conventional science. OA is age related chronic degenerative disease characterized by deterioration of cartilage of joints that results in bone rubbing together and creating stiffness, pain and impairment in movement.

          Osteoarthritis is second most common rheumatological problem with prevalence of 22% to 39% in India. By 2025 India may become the osteoarthritis capital of the world with over 60 million cases. Almost all persons over the age 40 have some bodily transformation in weight bearing joints. And this prevalence of OA is increasing with age and risk factors.The treatment of osteoarthritis mainly focuses on pain management using NSAIDS, Topical Analgesics, corticosteroids injection and lastly joint replacement surgery.  As OA is an inevitable part of ageing, there is no other satisfactory treatment. As long-term intake of oral medication has its own side effects, so to deal with chronic joint diseases Ayurvedic management seems to be the best.

           Panchamoolabalasiddha Ksheera is indicated in Vataja vikara. Acharya Charaka mentions that whatever the medicine indicated in particular disease can be used in the form of basti.Panchamoola (laghu panchamoola) contains tikta,madhura rasa pradhana dravyas having vataghna, brumhana, balavardhana property, which helps in samprapti vighatana of the disease. In present scenario Kala Basti mentioned by Acharya Charaka is widely practiced, while Kala Basti mentioned by Kashyapa and Vagbhata are usually not in practice, as in today’s era everyone has busy schedule, hence an attempt is made to evaluate the effect of these two patterns of Kala Basti having maximum number of Anuvasana Basti in minimum duration using Panchamoolabalasiddha Ksheera Basti in Janu Sandhigatavata.

 

 
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