FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:PCS||. Ayurveda Condition: ANGAMARDAH (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.

 
Close