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CTRI Number  CTRI/2025/05/087520 [Registered on: 23/05/2025] Trial Registered Prospectively
Last Modified On: 23/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   TO STUDY THE EFFECT OF LOCAL APPLICATION OF MANSADI UPNAHA IN THE MANAGEMENT OF NIRUPASTAMBHITA SANDHIGATA VATA WITH SPECIAL REFERENCE TO OSTEOARTHRITIS OF KNEE JOINT  
Scientific Title of Study   A randomised controlled clinical study to evaluate the efficacy of local application of mansadi upnaha in the management of nirupastambhita sandhigatavata with special reference to osteoarthritis of knee joint  
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 Namrata Arun Singh 
Designation  PG scholar 
Affiliation  R A Podar ayu medical college Worli Mumbai  
Address  OPD No.18, Kayachikitsa Department, M A Podar Hospital,R A Podar Govt(Ayu) college,Worli,Mumbai 18 Mumbai

Mumbai
MAHARASHTRA
400018
India 
Phone  8454831763  
Fax    
Email  nammo141998@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Dilip Uttamrao Wange 
Designation  Associate professor 
Affiliation  R A Podar medical college, Worli 
Address  OPD No.18, Kayachikitsa Department, M A Podar Hospital,R A Podar Govt(Ayu) college,Worli,Mumbai 18 Mumbai

Mumbai
MAHARASHTRA
400018
India 
Phone  9892323677  
Fax    
Email  drdilip.wange@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Dilip Uttamrao Wange 
Designation  Associate professor 
Affiliation  R A Podar medical college, Worli 
Address  OPD No.18, Kayachikitsa Department, M A Podar Hospital,R A Podar Govt(Ayu) college,Worli,Mumbai 18 Mumbai

Mumbai
MAHARASHTRA
400018
India 
Phone  9892323677  
Fax    
Email  drdilip.wange@gmail.com  
 
Source of Monetary or Material Support  
R A podar medical College, worli 
 
Primary Sponsor  
Name  R A Podar Govt(Ayu) college, Worli, Mumbai-18 
Address  OPD No.18, Kayachikitsa Department, M A Podar Hospital,R A Podar Govt(Ayu) college,Worli,Mumbai 18 Mumbai 
Type of Sponsor  Government 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 Namrata Arun Singh  Mahadevi Anandilal Podar Govt hospital  OPD No.18, Kayachikitsa Department, M A Podar Hospital,R A Podar Govt(Ayu) college,Worli,Mumbai 18 Mumbai
Mumbai
MAHARASHTRA 
8454831763

nammo141998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
BORS committe of institution,R.A. podar medical (ayu college,worli)   Approved 
DEPARTMENT LETTER FOR GUIDE CHANGE   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-upanAha-karma, उपनाह-कर्म (Procedure Reference: Non classical, Procedure details: Dashmool & Bala Kwatha (decoction) will be formed by Kwatha (decoction) method.[58] • Mansa & tandul is added in kwatha & cooked well. • The Prakshep Churna & Udida flour will be added in decoction then milk is added and cook well for formation of thick consistency paste. • The paste will be formed & it will be cooked over the flame, add Mahamasha Tail in it, mixed it well, until it will become thick in consistency like Lapsi.[59] • After the thick paste will be formed & apply the thick paste over a piece of cloth as required as of patients joint measurement so as to cover the whole joint & keep it overnight.)
2Comparator ArmProcedure-upanAhasvedaH (sAgniH, उपनाहस्वेदः (साग्निः) (Procedure Reference: Non classical, Procedure details: Take medicinal powder in a pan add 100ml Goksheer & mix it well ● Now add Erandamul powder in it & add 100 ml of milk & mix it well. ● Now add Tila Kalka ,Saindhav Lavana , Tila Taila to it & ix it well)
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1)The patients having symptoms like- sandhishool, sandhiaatopa, pain during ankunchan prasaran
2)Subjects who are willing to give written content 
 
ExclusionCriteria 
Details  1) The patients with known case of R.A. , gout , and inflammatory arthritis.
2) Patients suffering from acute traumatic injury.
3) Patients suffering from any life-threatening disorders like cancer, HIV, etc.
4) Patients with any immunosuppressive treatment.
5) Patients with past history of atopy or allergic contact dermatitis.
6) Patients who are not ready to comply the trial protocol.
7) Patients not willing for follow up.
8) Patients with local skin disease like fungal, eczema, psoriasis. Etc
9) patients with fixed joint deformity.
10) Pt with uncontrolled DM 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To see the efficacy of local application of Mansadi Upnaha in the management of Nirupastambhita Sondhigata Vata.  28 days  
 
Secondary Outcome  
Outcome  TimePoints 
1) To study the pathophysiology of Sandhigata vata.
2) To compare the effect of Mansadi upnaha & Godhumadi upnaha in the management of Nirupastambhita Sondhigata Vata on symptoms like pain, range of movement. 
At 7th 14th 21st 28th 35th 42th 
 
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 3 
Date of First Enrollment (India)   05/06/2025 
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="1"
Months="0"
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   Introduction-
Sandhigatavata is th comonnest form of articular disorder. It coonly occur in old age dur to dhatu kshya. It limits daily activities. As sandhigata vata is one of the vata vyadhi, the person who indulges in vatkar agar nd vihar is more prone to this disease. As this disease is chronic in nature food, lifestyle has influenced on reliving and aggregating the symptoms of sandhigata vata. In the ayurvedic aetiopathogenesis and symptomalogy of sandhigata vata is described in co sized form.samdhigata vata was first described by archaya charaka as sandhigata Anila with symptoms of shotha which on palpation feels like a vag filled with air, and shula on pranarana and ankunchana( pain and flexon and extension of the joints. Archaya shushruta also mentioned shula and shotha in this diseased leading to the diminution (hanti) of the movement joints involved . Sandhigata vata can be caused by dhatu kshya and nargavrodha. Also the vata Prakopak nidan leading to vatvyadhi is considered. The duhsya such as rasa , rakta , Mansa, meda dhatu asthidhatu, kandara, peshi , snayu, and shleshmadharakala constituting asthi sandhi , ashivaha strotas is mainly affected in the disease. The word upnaha mens bandage with warms paste of medicament to the affected part of the body. In the dhatukshaya janya sandhivata vata is situated by ruksha , khara, shita , laghu , etc gunas.the application of upnaha diminished the viiated the vata gunas and ruduced the dhantu kshayajanya shool . According too acharya yograrnakara dhahan swedan and upnaha are main line of treatment for sandhigata vata improving joint functions 
 
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