| CTRI Number |
CTRI/2025/06/088968 [Registered on: 17/06/2025] Trial Registered Prospectively |
| Last Modified On: |
16/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Gunja Beej Churna Lepa (for local application) in Sandhigatavata Specially Over Knee Joint |
|
Scientific Title of Study
|
A Single Arm Clinical Study to Evaluate the Efficacy of Gunja Beej Abrus precatorius Linn. Churna Lepa In Sandhigatavata Specially Janu Sandhi |
| 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 Pooja Samadhan Tayde |
| Designation |
M.D.(Agadtantra) Scholar |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune |
| Address |
O.P.D NO 4 Agadtantra Department Ground Floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
O.P.D NO 4 Agadtantra Department Ground Floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8888946076 |
| Fax |
|
| Email |
poojasamadhantayde@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vidya Undale Newaskar |
| Designation |
Associate Professor |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune |
| Address |
O.P.D NO 4 Agadtantra Department Ground Floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
O.P.D NO 4 Agadtantra Department Ground Floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9422345801 |
| Fax |
|
| Email |
undale.vidya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja Samadhan Tayde |
| Designation |
M.D.(Agadtantra) Scholar |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune |
| Address |
O.P.D NO 4 Agadtantra Department Ground Floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
O.P.D NO 4 Agadtantra Department Ground Floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8888946076 |
| Fax |
|
| Email |
poojasamadhantayde@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAMS Sumatibhai Shah Ayurved College O.P.D NO 4 Agadtantra Department Ground Floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune 411028 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Pooja Samadhan Tayde |
| Address |
O.P.D NO 4 Agadtantra Department Ground Floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune 411028 Maharashtra India Edit || Delete
|
| Type of Sponsor |
Other [self] |
|
|
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 Pooja Samadhan Tayde |
Sane Guruji Arogya Kendra Malwadi Hadapsar Pune |
O.P.D NO 4 Agadatantra Department Ground Floor Sane Guruji Arogya Kendra Malwadi Hadasar Pune
Pune
MAHARASHTRA |
8888946076
poojasamadhantayde@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee MAMS Sumatibhai Shah Ayurved Mahavidyalaya And Sane Guruji Arogya Kendra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M20-M25||Other joint disorders. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gunja Beej, Reference: Bhavprakash vol .1 Madhyamkhanda 24/254, Route: Topical, Dosage Form: Lepa Churna, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: Grasantara bhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -Quantity of lepa -Area involved according to pain thickness-tanulepa |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient will be diagnosed on the basis of signs and symptoms of Sandhigatavata as per mentioned in classical text.
2.AGE 20-60 yrs
3.Selection will be done irrespective of caste,gender,economic status
|
|
| ExclusionCriteria |
| Details |
1.The patient is suffering from any major systemic disorder and autoimmune disorder
2.Open wound
3.Accidental injury
4.Fracture
5.Pitta prakruti
6.Grudhrasi
7.Dhatukshayajanya sandhigatavata |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
vas scale
To evaluate the efficacy of Gunja Beej Churna lepa in sandhigatavata specially janusandhi |
At base line 7th ,14th, 21th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
28/06/2025 |
| 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="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
|
Sandhigatavata, Sandhi is anatomical aspect and Vata is physiological aspect of the body .It is type of Vata Vyadhi which commonly occurs in old age due to Vata vitiation and depletion of body tissues (Dhatus), sandhigatavata has symptoms of a shotha (swelling),which is palpable as vatapurna driti sparsha and akunchana prasarana vedana (pain on flexion and extension of the joints). Today’s modern life style and changed dietary habits among the people has led them to suffer from number of joint disease which even hamper their daily routine activity .In ayurved, various toxic herbal drugs are mentioned to have medicinal properties in number of disease when they are utilized wisely in proper dose and sufficient care. Gunja beej churna lepa is economic and have fast relief of action due to its vyavayi, vikasi and ahukari guna. Modern analgesics , anti-inflammatory drugs are very costly and have temporary effect so effect of gunja beej churna lepa in sandhigatavata will be assessed. |