| CTRI Number |
CTRI/2024/12/078015 [Registered on: 12/12/2024] Trial Registered Prospectively |
| Last Modified On: |
07/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A Comparative Clinical Study of Ajmodadi Vatak and Asitakadi Churna along with Ahinstradi Lepa in the Management of Amavata |
|
Scientific Title of Study
|
A Comparative Clinical Study of Ajmodadi Vatak and Asitakadi Churna along with Ahinstradi Lepa in the Management of Amavata. |
| Trial Acronym |
Interventional |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PRAMODEKKA |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pramod Ekka |
| Designation |
Pg Scholar Department of Kayachikitsa |
| Affiliation |
Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur Chhattisgarh |
| Address |
Opd No 2 And 18,Department of Kayachikitsa Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur Chhattisgarh 492010
Raipur
CHHATTISGARH
492010
India |
| Phone |
7999593057 |
| Fax |
|
| Email |
pramodekka0497@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aruna Ojha |
| Designation |
Proffesor in Department of Kayachikitsa |
| Affiliation |
Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur Chhattisgarh |
| Address |
Opd No 2 And 18,Department of Kayachikitsa Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur Chhattisgarh 492010
Raipur
CHHATTISGARH
492010
India |
| Phone |
9424401858 |
| Fax |
|
| Email |
arunaojha90@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi Diwan |
| Designation |
Lecturer in Department of Kayachikitsa |
| Affiliation |
Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur Chhattisgarh |
| Address |
Department of Kayachikitsa Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur Chhattisgarh 492010
Raipur
CHHATTISGARH
492010
India |
| Phone |
9770933579 |
| Fax |
|
| Email |
rashmi.diwan3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kayachikitsa Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur Chhattisgarh 492010 |
|
|
Primary Sponsor
|
| Name |
Department of Kayachikitsa Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur |
| Address |
Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur Chhattisgarh |
| Type of Sponsor |
Other [Goverment Ayurved College Raipur Chhattisgarh 492010] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of kayachikitsa Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur Chhattisgarh |
Department of kayachikitsa Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur Chhattisgarh 492010 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pramod Ekka |
Department of Kayachikitsa Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur |
Opd No 2 and 18,Department of Kayachikitsa Shri Narayan Prasad Awasthi Goverment Ayurved College Raipur Chhattisgarh 492010
Raipur
CHHATTISGARH |
7999593057
pramodekka0497@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Goverment Ayurved College Raipur Chhattisgarh 492010 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: ajmodadai vatak, Reference: bhaishajyaratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: koshna jala), Additional Information: ahinstradi lepa local application | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: asitakadi churna, Reference: bhavprakash nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: koshna jala), Additional Information: ahinstradi lepa loacal application |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
According to Symptoms of Aamvata given in Samhitas
According to Symptoms of Modern Text and Acr Criteria 2010
|
|
| ExclusionCriteria |
| Details |
Pateint Age Less Than 18 Years and More Than 70 Years
Chronic Cardiac Illness
Skin Cancer
Heigh Grade Dm
Fracture and Trauma on Specified Joints
Pregnant Lady and Lactating Mother
Gout,Oa and Infectious Joint Disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce the Symptoms of Amavata especially Pain in Joints,Swelling in Joints,Tenderness in Joints,Morning Stifness |
Reduce the Symptoms of Amavata especially Pain in Joints,Swelling in Joints,Tenderness in Joints,Morning Stifness |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improve in quality of life |
60 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/02/2025 |
| 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
|
For the present
study, on aamvata as shaman therapy, the medicine I choose is a suitable
natural product that will make it possible for patients to live a high quality
of life along with reducing the specific symptoms of morning stifness, tenderness in
joints swelling in joints pain in joints
These medicines have properties of vatakapha samak,
aampachak, agnideepak, rasayan and vedna sthapak shothhar without any side
effects in our texts. Considering the magnitude of aamvata I am doing a
comparative clinical study of ajmodadi vatak and asitakadi churna along with
ahinstradi lepa in the management of aamvata
the volunteers will be informed about the study protocol.
willing participants will be randomly selected . clinical research format will
be prepared and validated before the study approval will be taken from the IEC
of the NPA government Ayurved college and hospital, Raipur C.G. and CTRI
registration will be done. after selection, each participant will be tasted
individually and selected according to the selection criteria.
Forty patients of aamvata will be selected from Kayachikitsa
OPD and IPD Shri NPA government Ayurved college and hospital, Raipur C.G. The case
selection was in regards to age, sex, occupation, and socioeconomic conditions.
Both acute and chronic phases of aamvata
The present study is
a prospective, interventional, single-arm, open-labeled non-randomized clinical
comparative study. A total of 40
clinically diagnosed and registered patients of aamvata were divided randomly
by coin method into two groups. Each group will have 20 patients.
Group A: 20
clinically diagnosed patients of aamvata will be treated with ajmodadi vatak 5gm
two times in a day before meal with luke warm water and for external application
ahinstradi lepa
Group B: 20 clinically diagnosed patients of aamvata were
treated with asitkadi churna 5gm two times in a day before meal with luke warm water
and for external application ahinstradi lepa
Ingredient of ajmodadi vatak :- ajmoda,pippali,marich,chitrak,devdaru,
saunfh,saindhav vidhara,vayavidanga, haritki
Ingredient of asitkadi churna :- vishnukranta,pippali,guduchi,kalanishoth,vaarahikand,erandamool,shonth,
Ingredient of ahinstradi lepa :- kantkari, kevuk,sahijanbark,
Valmik mritika.
|