| CTRI Number |
CTRI/2023/05/052576 [Registered on: 12/05/2023] Trial Registered Prospectively |
| Last Modified On: |
11/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical study to evaluate the effect of Nyagrodhadi Lepa in Aghataj Sandhigata Shotha |
|
Scientific Title of Study
|
A clinical study to evaluate the effect of Nyagrodhadi Lepa in Aghataj Sandhigata Shotha |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anil Kumar Sharma |
| Designation |
Reader |
| Affiliation |
Rajiv Gandhi Post Graduate Ayurvedic College and Hospital Paprola Himachal Pradesh |
| Address |
Room no 206 Deparment of Shalya Tantra Anatomy Block .
Rajiv Gandhi Post Graduate Ayurvedic College and Hospital Paprola Himachal Pradesh
211 OPD Deptt of Shalya Tantra Rajiv Gandhi Post Graduate Ayurvedic College and Hospital Paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9805056393 |
| Fax |
01894242064 |
| Email |
dranilpaprola@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Kumar Sharma |
| Designation |
Reader |
| Affiliation |
Rajiv Gandhi Post Graduate Ayurvedic College and Hospital Paprola Himachal Pradesh |
| Address |
Room no 206 Deparment of Shalya Tantra Anatomy Block .
Rajiv Gandhi Post Graduate Ayurvedic College and Hospital Paprola Himachal Pradesh
OPD No 211 Deparment of Shalya Tantra.
Rajiv Gandhi post Graduate Ayurvedic College and Hospital Paprola Himachal Pradesh
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9805056393 |
| Fax |
01894242064 |
| Email |
dranilpaprola@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Urvashi |
| Designation |
PG Scholar |
| Affiliation |
Rajiv Gandhi Post Graduate Ayurvedic College and Hospital Paprola |
| Address |
Rajiv Gandhi Post Graduate Ayurvedic College and Hospital Paprola Himachal Pradesh.
Room no 321 Rajiv Gandhi Post Graduate Ayurvedic College and Hospital Paprola Himachal Pradesh
Kangra
HIMACHAL PRADESH
17615
India |
| Phone |
9896588408 |
| Fax |
01894242064 |
| Email |
urvashithakur327@gmail.com |
|
|
Source of Monetary or Material Support
|
| Baijnath pharmacy , Paprola ,District Kangra , Himachal Pradesh Charak pharmacy, R.G.G.P.G Ayurvedic college , Paprola , Kangra Research institute in I.S.M Jogindernagar , Himachal pradesh |
|
|
Primary Sponsor
|
| Name |
Principal RGGPG Ayurvedic College and Hospital Paprola |
| Address |
Rajiv Gandhi Post Graduate Ayurvedic College and Hospital Paprola |
| 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 Anil Kumar Sharma |
R.G.G.P.G Ayurvedic College and Hospital Paprola Himachal Pradesh |
OPD 211 Shalya Tantra Deptt .
Rajiv Gandhi Post Graduate Ayurvedic College and Hospital Paprola Himachal Pradesh
Kangra
HIMACHAL PRADESH |
9805056393
01894242064
dranilpaprola@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Human R.G.G.P.G Ayurvedic College and Hospital Paprola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M708||Other soft tissue disorders related to use, overuse and pressure. Ayurveda Condition: Aghataj Sandhigata Shotha , (2) ICD-10 Condition:M709||Unspecified soft tissue disorder related to use, overuse and pressure. Ayurveda Condition: Aghataj Sandhigata Shotha, (3) ICD-10 Condition:M709||Unspecified soft tissue disorder related to use, overuse and pressure. Ayurveda Condition: Aghataj Sandhigata Shotha, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: यो. र. उ. शोथ चिकितà¥à¤¸à¤¾, Procedure details: To use the Nyagrodhadi Lepa in Aghataj Sandhigata Shoth .)
(1) Medicine Name: Nyagrodhadi Lepa , Reference: यो. र . उ. शोथ चिकितà¥à¤¸à¤¾, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: bd, Duration: 10 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient wiling for trial .
Patient of age group above 18 and below 70.
Patient with history of soft tissue injuries sprains and strains randomly selected . |
|
| ExclusionCriteria |
| Details |
Patient not willing for trail or not ready to give informed consent.
Patient having fracture and dislocation.
Patient having uncontrolled hypertension,diabetes mellitus.
Patient having rheumatoid arthritis,gouty arthritis,allergic to any drug or any other life threatening disease like history of IHD ,MI etc . |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A clinical study to evaluate the effect of Nyagrodhadi Lepa in Aghataj Sandhigata Shotha |
8 to 10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Generate feeling of well-being |
7 days to 10 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/06/2023 |
| 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="0"
Months="0"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To assess the efficacy of Nyagrodhadi Lepa , and to come up with an effective ayurvedic ghrita for Aghataj Sandhigata Shotha.Thirty patients will be selected randomly.Duration of trail 7 to 10 days .Application of Lepa -Lepa will be applied twice a day after hot water fomentation minimum for 10 to 15 minutes to involved joint , time period maximum 1 hour , thickness of Lepa approx 3 to 4 mm. |