| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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.)
| | 2 | Comparator Arm | Procedure | - | 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)
|
|
|
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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 |
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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 |