| CTRI Number |
CTRI/2025/01/079310 [Registered on: 23/01/2025] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect Of Shushkamuladi Taila In Traumatic Inflammation |
|
Scientific Title of Study
|
Randomised Controlled Clinical Trial To Study Efficacy Of Shushkamuladi Taila In Management Of Aghataj Shotha W.S.R. To Traumatic Inflammation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shubham Dnyaneshwar Belhekar |
| Designation |
M.S. Scholar Shalyatantra Samanya Department |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik |
| Address |
Department of Shalyatantra Samanya, Shree Saptashrungi Ayurved
Mahavidyalaya,Kamal nagar Hirawadi, Panchavati, Nashik,
Maharashtra 422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
9284141003 |
| Fax |
|
| Email |
shubhambelhekar18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Vanaji Ahire |
| Designation |
Associate Professor |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik |
| Address |
Department of Shalyatantra Samanya, Shree Saptashrungi Ayurved
Mahavidyalaya,Kamal nagar Hirawadi, Panchavati,Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
917972360104 |
| Fax |
|
| Email |
ramesh.v.ahire@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramesh Vanaji Ahire |
| Designation |
Associate Professor |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik |
| Address |
Department of Shalyatantra Samanya, Shree Saptashrungi Ayurved
Mahavidyalaya,Kamal nagar Hirawadi, Panchavati,Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
917972360104 |
| Fax |
|
| Email |
ramesh.v.ahire@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of shalyatantra samanya, Shree Saptashrungi Ayurved Mhavidyalay And Hospital , Kamalnagar , Hirawadi , Panchwati, Nashik Maharashtra 422003 India |
|
|
Primary Sponsor
|
| Name |
Shree Saptashrungi Ayurved Medical College And Hospital , KamalNagar , Hirawadi , Panchwati, Nashik |
| Address |
Department of Shalyatantra Samanya, Shree Saptashrungi Ayurved
Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik,
Maharashtra 420003 |
| Type of Sponsor |
Private 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 Shubham Dnyaneshwar Belhekar |
Shree Saptashrungi Ayurved Medical College And Hospital |
Shree Saptashrungi
Ayurved Medical
College And Hospital,
KamalNagar , Hirawadi
, Panchawati , Nashik
420003
Nashik
MAHARASHTRA
Nashik
MAHARASHTRA |
9284141003
shubhambelhekar18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Shree Saptashrungi Ayurved Mahavidyalaya and Hospital panchawati Nashik Maharashtra 422003 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: Shoth, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shushkamuladi tail, Reference: Yogratnakar, Route: Topical, Dosage Form: Taila, Dose: 2(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Glycerin Mgso4 | Local application of Glycerin Mgso4 2ml soaked gause piece at site of inflammation with the help of gause piece and dressing done with rollar bandage 2 times per day for the 7 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Clinically diagnosed cases of Aghataj Shotha will be taken for the study.
2) Patients irrespective of sex, religion, occupation & economic status.
3)Patients between the age group of 18 to 60 years.
4) Shotha which are present to upper and lower extremities only.
5) Circumference of Shotha is approximately between 1cm-4cm as
compare to circumference of other extremity |
|
| ExclusionCriteria |
| Details |
1)Patients having Aghataj Shotha with bleeding disorder.
2)Patients with infectious diseases like HIV, HbsAg, HCV
3)Patient with uncontrolled Diabetes and Hypertension.
4) Not willing to give consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce the Sign And Symptoms Of Aghataj Shotha |
7days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Reduce Recurrence And Further Infection |
14 days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/02/2025 |
| Date of Study Completion (India) |
20/11/2025 |
| Date of First Enrollment (Global) |
02/02/2025 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Aim And Objectives :To assess the efficacy of Shushkamuladi tail in the management of Aghataj shotha
6.1) Primary objective:
1) To Study the efficacy of Shushkamuladi tail in the management of Aghataj shotha
6.2) Secondary objective:
1) To study the literature of Aghataj shotha in Ayurvedic classics.
2) To study the traumatic inflammation in modern literature.
3) To study detail about Glycerine Mgs04 dressing. Subject withdrawal criteria: -
1) If patients develop any adverse effect.
2) If patient is not responding to treatment and aggravation of symptoms.
3) If patient refuses to continue with the treatment.
4) Patient absent for follow up.
(vii) Methods of measurements
Subjective Parameters²: -
1)Vedana (pain)
2) Daha (Burning)
3)Shotha (swelling) |