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CTRI Number  CTRI/2023/10/058758 [Registered on: 17/10/2023] Trial Registered Prospectively
Last Modified On: 25/09/2023
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   To study the effectiveness of Kapikacchavadi Kwath Ghanvati & Lakshadi Guggul in the treatment of Sandhigatvata (Osteoarthritis) 
Scientific Title of Study   A Randomized controlled clinical study to evaluate the efficacy of Kapikacchavadi Kwath Ghanvati & Lakshadi Guggul in the management of Dhatukshayjanya Janusandhigatvata in age group 40 to 75 years 
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 Korde Vishal Bhagwan 
Designation  PG scholar 
Affiliation  PDEAs college Of Ayurved And Research Centre Nigdi Pune 
Address  PDEAs College Of Ayurved And Research Centre Kayachikitsa Department Third Floor sector 25,Nigdi Pradhikaran Pune Maharashtra 411044 India

Pune
MAHARASHTRA
411001
India 
Phone  9405329762  
Fax    
Email  vishalbhagwankorde@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Medha M Joshi 
Designation  Professor and HOD 
Affiliation  PDEAs college Of Ayurved And Research Centre Nigdi Pune 
Address  PDEAs College Of Ayurved And Research Centre Kayachikitsa Department Third Floor sector 25,Nigdi Pradhikaran Pune Maharashtra 411044 India

Pune
MAHARASHTRA
411001
India 
Phone  9881465798  
Fax    
Email  medhamaheshjoshi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Medha M Joshi 
Designation  Professor and HOD 
Affiliation  PDEAs college Of Ayurved And Research Centre Nigdi Pune 
Address  PDEAs College Of Ayurved And Research Centre Kayachikitsa Department Third Floor sector 25,Nigdi Pradhikaran Pune Maharashtra 411044 India

Pune
MAHARASHTRA
411001
India 
Phone  9881465798  
Fax    
Email  medhamaheshjoshi@gmail.com  
 
Source of Monetary or Material Support  
PDEAs College Of Ayurved And Research Centre Nigdi pune 
 
Primary Sponsor  
Name  PDEAs College Of Ayurved And Research Centre Nigdi Pradhikaran Pune 
Address  PDEAs Ayurved Rugnalaya and Sterling Multispeciality Hospital Kayachikitsa Department OPD no 117 sector 27 Nigdi Pradhikaran Pune Maharashtra 411044 India 
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 Korde Vishal Bhagwan  Ayurved Rugnalaya And Sterling Multispeciality hospital Pune  Ayurved Rugnalaya And Sterling Multispeciality hospital Sector No 27 Kayachikitsa Department Opd no 117 Nigdi Pradhikaran Pune 411044 Pune MAHARASHTRA
Pune
MAHARASHTRA 		 9405329762

vishalbhagwankorde@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Chaiman Institutional Ethics Committee college of Ayurveda and Research centre akurdi ,Pune 44  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: Kapikacchvadi kwath Ghanwati, Reference: Vrund Nighantu Ratnakar, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Koshnajal), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Lakshadi Guggul, Reference: Bhaishajya Ratnavali Bhagnrogchikitsa, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Koshnajal), Additional Information: -
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patients presenting any 2 or more classical signs and symptoms of
Dhatukshayajanya Janusandhigatvata
I. Janusandhi Shula
II. Janusandhi Shotha
III. Janusandhi Stambha
IV. Janusandhi Sphutana
V. Aakunchana Prasarana kasthta
VI. Vatapurna Druti Sparsha
will be taken for the study.
2. Patients of either sex aged between 40 – 75 years.
Investigation –
X – Ray of knee joint AP and LT view only before starting the study
 
 
ExclusionCriteria 
Details  1) Major systemic disorders like cancer , cirrhosis of liver , kidney failure ,
2) patients with known case of autoimmune disorder like rheumatoid
arthritis, psoriatic arthritis, gouty arthritis, systemic lupus erythematosus
(SLE), bone Tuberculosis, injuries and other serious systemic disorders of knee
joint.
3) Fracture of knee joint.
4) Direct and indirect infection of knee joint.
5) History of any surgical procedure of knee joint.
6) Any anatomical deformity
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.To study the efficacy of Kapikachhavadi Kwath Ghanwati and Lakshadi Guggul in the management of
Dhatukshayajanya Janusandhigatvata in age group 40 to 75 years for 2 months
2.To reduce the symptoms of Dhatukshayjanya Janusandhigatvata 		 60 days study
follow up at 15th, 30th, 45th 60th day 
 
Secondary Outcome  
Outcome  TimePoints 
To observe the adverse effect if any  60 days study
follow up at 15th, 30th, 45th 60th day 
 
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   N/A 
Date of First Enrollment (India)   28/10/2023 
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="6"
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   Dhatukshayjanya Janu Sandhigatavata is the most common joint disorder and one of the most common sources of pain and disability in the elderly. Different modalities of treatment have been explained in Ayurveda to tackle the condition effectively. Sandhigatvata explained under Vat vyadhi and first described by Acharya Charak as symptoms of Shotha which on palpation feels like a bag filled with air and Shula on Akunchan Prasaran.Acharya Sushrut also mentioned shula and shotha in this disease leading to reduction of the movement involved . Madhavkara describes Atopa that is crepitus in joint as additional feature in It. Vata dosha plays main role in this disease. As age advances Vata dosha increases in an individual, thus advancing age makes man prone to many diseases including degenerative disorders. 
Dhatukshayjanya Janu Sandhigatvat is one of the Vatavyadhi caused due to impairment of Vata dosha.References of this disease is given in Brihatrayias well as Madhavnidan. The etiopathogenesis and management of Dhatukshayjanya Sandhigatvata is mentioned in Brihatrayias. In today’s era there has been drastic change in lifestyle , improper sleep , continuous work in one posture , improper sitting posture ,excessive travelling and eating patterns due to growing industrialization and modernization which affects the Skeletal health and leading to various joint disorders. In India 20 million peoples are suffered from sandhigatavata and is most frequent joint disease with prevalence of 22 % to 39 % in india . It is more common in women than in men but prevalence increases dramatically with age.As described above the modern life style leads to impairment of Jatharagni and variations in Tridoshas, which is described as the main cause of all diseases and especially leading to various joint disorder. As Dhatukshayajanya Sandhigatavata is mostly observed at Janusandhi . Dhatukshaya or degenerative joint disorder are observed in old age but also seen at the age of 40 ’s . Though this disease is not fatal but can be cause for the disability and hampering the quality of life . Hence there is a need of drug which can control the disease and prevents the future joint degeneration. Lakshadi Guggul was studied and found significantly effective on Dhatukshayajanya Janusandhigatavata the trial drug i.e. Kapikacchavadi Kwath Ghanvati is mentioned effective in Dhatukshayajanya Janusandhigatavat. Therefore, chosen for present study and this drug explained in Vrund Nighantu Ratnakar in Vatvyadhi Prakaran named as Kapikacchavadi Kwath Ghanvati. No other work has been done on as Kapikacchavadi Kwath Ghanvati with Lakshadi Guggul in management of Dhatukshayjanya Janusandhigatvata , hence this formulation selected for the study. The content of this drug is easily available and cost effective , Hence Kapikacchavadi Kwath Ghanvati is selected for the management of Dhatukshayajanya Janusandhigatvata . 
 
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