| CTRI Number |
CTRI/2025/02/079844 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
27/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To find the efficacy of Angamardprashaman mahakashay Vati in Angamarda |
|
Scientific Title of Study
|
Clinical Study to Evaluate the Efficacy of Angamardaprashaman Mahakshay on Angamarda |
| 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 Prajakta Sadanand Kakade |
| Designation |
M.D Scholar Kriya Sharir Department |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital |
| Address |
Department of Kriya Sharir ,Shree Saptashrungi Ayurved Mahavidyalaya, Kamal nagar Hiravadi,Panchavati,Nashik,Maharashtra 420003
Nashik
MAHARASHTRA
Department of Kriya Sharir ,Shree Saptashrungi Ayurved Mahavidyalaya, Kamal nagar Hiravadi,Panchavati,Nashik,Maharashtra 420003
Nashik
MAHARASHTRA
422003
India |
| Phone |
9604628129 |
| Fax |
|
| Email |
prajaktakakade98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prakash Chondikar |
| Designation |
H.O.D |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital |
| Address |
Department of Kriya Sharir ,Shree Saptashrungi Ayurved Mahavidyalaya, Kamal nagar Hiravadi,Panchavati,Nashik,Maharashtra 420003
Nashik
MAHARASHTRA
Nashik
MAHARASHTRA
422003
India |
| Phone |
9890096200 |
| Fax |
|
| Email |
prakashachondikar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prajakta Sadanand Kakade |
| Designation |
M.D Scholar Kriya Sharir Department |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya and Hospital |
| Address |
Department of Kriya Sharir ,Shree Saptashrungi Ayurved Mahavidyalaya, Kamal nagar Hiravadi,Panchavati,Nashik,Maharashtra 420003
Nashik
MAHARASHTRA
Nashik
MAHARASHTRA
422003
India |
| Phone |
9604628129 |
| Fax |
|
| Email |
prajaktakakade98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Saptashrungi Ayurved Mahavidyalaya and Hospital Kamal Nagar Hirawadi Panchavati Nashik 422003 |
|
|
Primary Sponsor
|
| Name |
Shri Saptashrungi ayurved mahavidyalaya and hospital |
| Address |
Shree Saptashrungi ayurved mahavidyalaya and hospital Kamalnagar Hirawadi Panchavati Nashik 422003 |
| 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 |
| DrPrakash Chondikar |
Shree Saptashrungi Ayurved Mahavidyala And Hospital |
Department of Kayachikitsa opd no.2 Ground floor Shree Saptashrungi Ayurved Mahavidyalaya and Hospital Kamal Nagar Hirawadi Panchavati Nashik 422003
Nashik
MAHARASHTRA |
9604628129
prajaktakakade98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Shree Saptashrungi Ayurved Mahavidyalaya Nash |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
100 |
| Patients |
(1) ICD-10 Condition:M628||Other specified disorders of muscle. Ayurveda Condition: ANGAMARDAH (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Angamardprashaman Mahakashay Vati, Reference: Charak, Route: Oral, Dosage Form: Varti/ Suppository, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Days, anupAna/sahapAna: Yes(details: Koshna Jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient having angamarda as a symptom.
2. Patient having age group between 18-50 years
3. Patient working in shift duty.
4. Patient irrespective of gender. |
|
| ExclusionCriteria |
| Details |
1. Pregnant ladies and lactating mothers.
2. Having body ache for more than 1 month
3. Patient having any known disease like HTN, DM, or any surgery or injury or any infections
4. Patients who gets relief of angamarda after rest |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce the symptom of angamarda |
3 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No Recurrence of angamarda |
7 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/ Phase 3 |
|
Date of First Enrollment (India)
|
10/02/2025 |
| 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 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
|
Primary Objective :-
1. To study the efficacy of angamardaprashaman mahakashay on angamarda
Secondary Objective :-
To study the cause or hetu of angamarda in detail
2. To study angamardaprashaman mahakashay
Participants :-
100 Adults with angamarda a symptom meeting inclusion & exclusion criteria from opd of kaychikitsa department of Shree Saptashrungi Medical College and Hospital, nashik
Intervention :-
100 patients of angamarda are Administered with angamardaprashaman mahakashay according to standardized protocol
Primary Outcome :-
Reduce the symptoms of angamarda
Secondary Outcome :-
Reducing the hetu of angamarda
To reduce the recurrence
Treatment Duration :- 3 days
Follow Up :- 0th, 3rd
Data Analysis - Data will be analysed using appropriate statistical methods to compare the effectiveness of the intervention on the primary and secondary outomes Ethical consideration - The study will be conducted in accordance with ethical guidelines and with informed consent from participants. |