CTRI Number |
CTRI/2021/02/031222 [Registered on: 11/02/2021] Trial Registered Prospectively |
Last Modified On: |
03/02/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Single Arm Study |
Public Title of Study
|
A clinical trial to see the efficacy of angamardaprashamana ghanavati in patients with chronic fatigue syndrome and repetitive stress injury |
Scientific Title of Study
|
A conceptual and applied study on angamardaprashamana mahakashaya vis-a-vis chronic fatigue syndrome and repetitive stress injury |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Kavya K |
Designation |
PG Scholar |
Affiliation |
Government Ayurveda Medical College and Hospital, Mysuru |
Address |
Department of Ayurveda Samhita and Siddhanta, Government Ayurveda Medical College and Hospital, Mysuru
Mysore KARNATAKA 570001 India |
Phone |
8792101063 |
Fax |
|
Email |
Kavyagowda8792@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Shreevathsa |
Designation |
BAMS, MD, HOD |
Affiliation |
Government Ayurveda Medical College and Hospital, Mysuru |
Address |
HEAD of Department of Ayurveda Samhita and Siddhanta, Government Ayurveda Medical College and Hospital, Mysuru
Mysore KARNATAKA 570001 India |
Phone |
9449772701 |
Fax |
|
Email |
dr.shreevathsa@rediffmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Kavya K |
Designation |
PG Scholar |
Affiliation |
Government Ayurveda Medical College and Hospital, Mysuru |
Address |
Department of Ayurveda Samhita and Siddhanta, Government Ayurveda Medical College and Hospital, Mysuru
Mysore KARNATAKA 570001 India |
Phone |
8792101063 |
Fax |
|
Email |
Kavyagowda8792@gmail.com |
|
Source of Monetary or Material Support
|
Government Ayurveda Medical college and Hospital, Vishweshwarayya circle, New sayyaji rao road, near Mandi mohalla, Mysore - 570001 |
|
Primary Sponsor
|
Name |
Dr Kavya K |
Address |
Government Ayurveda Medical College and Hospital, Mysuru |
Type of Sponsor |
Other [Student] |
|
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 Kavya K |
Government ayurveda medical college and hospital |
Kayachikitsa opd, room number-10 and Panchakarma opd, room number-14 of government ayurveda medical hospital, vishweshwarayya circle, new sayyaji rao road, near mandi mohalla, mysuru Mysore KARNATAKA |
8792101063
Kavyagowda8792@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Dr Kavya K |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:PCS||. Ayurveda Condition: ANGAMARDAHÂ (KEVALAVATA), |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Angamardaprashamana mahakashaya ghanavati |
Drugs: vidariganda, prushnaparni, bruhati, Kantakarika, eranda, Kakoli, Chandana, ushira, ela and madhuka
Dose: 500mg, 2 tablets
Frequency: TID
Route of administration: oral
Duration: 24 days |
Comparator Agent |
Nil |
Nil |
|
Inclusion Criteria
|
Age From |
25.00 Year(s) |
Age To |
45.00 Year(s) |
Gender |
Both |
Details |
Chronic fatigue syndrome
1. Subjects presenting with classical features of Chronic fatigue syndrome & fulfilling diagnostic criteria.
Repetitive stress injury
1. Subjects using computer >40 hours/ week (Approx.5-6 hours/day)
2. Stage III Repetitive stress injury
3. subjects fulfilling diagnostic criteria.
4. Subjects willing to participate.
|
|
ExclusionCriteria |
Details |
Chronic fatigue syndrome
1. Subjects having any other medical condition explaining fatigue
2. Major depressive disorders (psychotic features) or bipolar disorders.
3. Schizophrenia, dementia or delusional disorders
4. Anorexia nervosa, bulimia nervosa
5. Alcohol or substance abuse
6. Severe obesity (BMI>40)
Repetitive stress injury
1. Any H/O upperlimb fracture
2. Any H/O pathological disorders of upperlimb
3. All regular exercise
4. Subjects with Congenital anomalies
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
|
Blinding/Masking
|
|
Primary Outcome
|
Outcome |
TimePoints |
Reduction in the signs and symptoms of chronic fatigue syndrome and Repetitive stress injury |
4 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
Nature and presentation of the disease can be known |
4 weeks |
|
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 2 |
Date of First Enrollment (India)
|
18/02/2021 |
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 Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
“Sukha sanjnakam Aarogyam vikaro dukhameva ca|†as quoted by Acharya charaka states that, the experience of positive stimuli (sukhasamjna) is termed as Arogya & contrary to this is Vikara, here vikara means vedana. Vedana is mainly of two types i.e., Anukulakaravedana(sukha) & Pratikulakaravedana(dukha). There are many experiences that cause pratikulavedana, Angamarda is one among them. “Angamarde rogalakshanaha†i.e., Angamarda is prominent feature which is specifically seen in different conditions. “Anganaamvimrudhyante iva†i.e., Angamarda is a sense of pain & uneasiness which is a common feature as well as a specific feature in Chronic fatigue syndrome & Repetitive stress injury. Chronic fatigue syndrome is a debilitating disorder characterized by persistent & un-explained Fatigue that lasts for 6 months, resulting in severe impairment in daily functioning along with concomitant symptoms such as pain etc. with prevalence rate varying between 0.2-0.4%. And Repetitive stress injury is an another clinical condition, seen commonly in all age group of patients, caused due to exhaustive physical and psychological activities such as exposures to mechanical vibrations, less active body postures etc., It affects the ability to work & live normally without pain. It has the prevalence rate of ~1% in India. By considering the practical challenges in diagnosis & management of Chronic fatigue syndrome and Repetitive stress injury, it is essential to analyse the pathology involved in these conditions and formulate an effective remedy through Ayurveda seems to be the best alternative. It is evident that, the clinical condition angamarda is vastly associated with many clinical illness found in Ayurveda literatures. In the current study, the concept of Angamarda and Angamardaprashamana gana dravya has been hypothetically taken to understand as well as to evaluate the clinical efficacy of the same in chronic fatigue syndrome and repetitive stress injury. Hence the present study entitled, “A CONCEPTUAL & APPLIED STUDY ON ANGAMARDAPRASHAMANA MAHAKASHAYA VIS-À-VIS CHRONIC FATIGUE SYNDROME & REPETITIVE STRESS INJURY†shall be undertaken. |