| CTRI Number |
CTRI/2024/07/071571 [Registered on: 30/07/2024] Trial Registered Prospectively |
| Last Modified On: |
26/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of Ashwagandha churna on Sandhigatavata with referance to serum calcium |
|
Scientific Title of Study
|
Single arm clinical study To evaluate the efficacy of Ashwagandha churna in Dhatukshayajanya Sandhigatavata with special reference to serum calcium |
| 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 Vijay Hanumantrao Uphad |
| Designation |
PG Student |
| Affiliation |
LRP Ayurvedic medical collage and reserch center ,urun islampur |
| Address |
Room No 1 Rognidan Department LRP Ayurvedic Medical Collage And Hospital and Resaerch Center Urun Islampur Taluka Walva District Sangli
LRP Ayurvedic Medical Collage And Research Center Urun Islampur Taluka Walva District Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9156521381 |
| Fax |
|
| Email |
vijayuphad777@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhimanyu patil |
| Designation |
Dean and Professor |
| Affiliation |
LRP Ayurvedic medical collage and reserch center ,urun islampur |
| Address |
Room no 1 Rognidan Department LRP Ayurvedic Medical Collage And Hospital and Research Center Urun Islampur Taluk Walva District Sangli
LRP Ayurvedic Medical Collage And Research Center Urun Islampur Tal.Walva Dist.Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9960538603 |
| Fax |
|
| Email |
manyupatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay Hanumantrao Uphad |
| Designation |
PG Student |
| Affiliation |
LRP Ayurvedic medical collage and reserch center ,urun islampur |
| Address |
Room No 1 Rognidan department LRP Ayurvedic Medical Collage And Hospital and Research Center Urun Islampur Tal.Walva Dist.Sangli
LRP Ayurvedic Medical Collage And Research Center Urun Islampur Tal.Walva Dist.Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9156521381 |
| Fax |
|
| Email |
vijayuphad777@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic Medical Collage And Hospital Resaerch Center Urun Islampur Taluka Walva Distrct Sangli Pin code 415409 Maharastra India |
|
|
Primary Sponsor
|
| Name |
Dr Vijay Hanumantrao Uphad |
| Address |
LRP Ayurvedic Medical Collage And Hospital And Reserch Center Urun Islampur Tal.Walva Dist.Sangli 415409 Maharastra India |
| Type of Sponsor |
Other [] |
|
|
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 Vijay Hanumantrao Uphad |
LRP Ayurvedic Medical Collage And Hospital |
Room no 1 Rognidan Department LRP ayurvedic Medical Collage And Hospital Research center Urun islampur Taluka Walva District Sangli 415409
Sangli
MAHARASHTRA |
9156521381
vijayuphad777@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M199||Osteoarthritis, unspecified site. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ashwagandha , Reference: Sankhyadhar.S , Sankhyadhar.D,Chunekar (Eds),Raj Nighatu of Pandit Narhari, Edition 1st,Varanasi, Page No 97,Shloka No.112 22. Sharma PV. Dhanvantari Nighantu,Chaukhamba orientalia,Varanasi ,Edition 3rd 2002,Page No.85 Shloka no.273, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients With Sign and Symptoms Of Sandhigatvata
2. Patients will be Selected Irrespective Of Sex Religion |
|
| ExclusionCriteria |
| Details |
1.Patients With Acute Trauma of Joint
2.Patient with Any Systemic and Chronic Illness
3.Pregency and lacticting Mother |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Study the Sandhigatavata According to Ayurvedic Literature
2.To study the osteoarthritis
3.To study the sr. calcium
4.To study the sr.calcium level in Sandhigatavata using Ashwagandha Churna |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Ayurvedic Formulation |
30 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
07/08/2024 |
| 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="0"
Months="6"
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
|
Sandhigatavata Acharyas of Ayurveda (Charaka , Sushrut and Vagbhata ) have included Vatavyadhi in Astamahagada .There are several Vatavyadhi out of which Sandhigatvata is one of the most common .Acharyas explained this vyadhias Sandhigatanile with clinical signs and symptoms of Shotha(oedema),Vatapurnadritisparsha (on palpation revealed as air filled bags ) and pain with Prasarana andAkunchana ( movement ).In old age, all Dhatus undergo Kshaya (degeneration), thus this leadsto Vataprakopa and making individual prone to many diseases. Among them Sandhigatvata(Osteoarthritis)is on top most position. Sandhigatvata may occur in any joint of the body. Etiological factors has been explained by Charaka Acharya for vitiation of Vata including diet habit,depletion of Dhatu and path obstruction of Vata Vitated vata is them ainfactorin Sandhigatvata. The description of Sandhigatvata in classical Ayurvedic texts closely resembles to the condition of Osteoarthritis in modern science. Osteoarthritis is an abnormality of synovial joints characterized by softening, splitting and fragmentation (fibrillation) of auricular cartilage not attributed to direct contact within inflammatory tissue
Serum Calcium is a blood test to measure the amount of calcium in the blood. Serum calcium is measured to monitor bone disease or calcium regulation disorder .That’s why the test can be applicable in Dhatukshayaja Sandhigatvata that is osteoarthritis.
Ashwagandha churna retain calcium and phosphorus in body. Ashwagandha is vatahara so it is useful in vata vyadhi.
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