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CTRI Number  CTRI/2022/12/047847 [Registered on: 02/12/2022] Trial Registered Prospectively
Last Modified On: 01/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of AÅ›vagandha cÅ«rṇa and Selected Yoga module in Mild To Moderate Geriatric Depression  
Scientific Title of Study   Effect AÅ›vagandha cÅ«rṇa and Selected Yoga module in Mild to Moderate Geriatric Depression – Single Group Pre-Test Post-Test Design 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SREEJU M P 
Designation  PG Scholar 
Affiliation  VPSV Ayurveda College, Kottakkal 
Address  MD scholar Manovigyan avum manasroga VPSV Ayurveda College Kottakkal

Malappuram
KERALA
676501
India 
Phone  9747165845  
Fax    
Email  sreejump93@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vinod R 
Designation  Associate Professor 
Affiliation  VPSV Ayurveda College, Kottakkal 
Address  Department of Kayacikitsa VPSV Ayurveda College Kottakkal

Malappuram
KERALA
676501
India 
Phone  9846302667  
Fax    
Email  drvinodvarier@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vinod R 
Designation  Associate Professor 
Affiliation  VPSV Ayurveda College, Kottakkal 
Address  Department of Kayacikitsa VPSV Ayurveda College Kottakkal

Malappuram
KERALA
676501
India 
Phone  9846302667  
Fax    
Email  drvinodvarier@gmail.com  
 
Source of Monetary or Material Support  
1)saketham charitable trust, perinthalmanna,Malappuram,kerala 2)abhayam, koppam, palakkad, kerala 3)salva care home, pandikkad, malappuram , kerala 
 
Primary Sponsor  
Name  SREEJU M P 
Address  MD Scholar Manovigyan avum Manasroga VPSV Ayurveda college Kottakkal 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sreeju M p  abhayam  koppam P O Pulassery
Palakkad
KERALA 		 9747165845

sreejump93@gmail.com 
Sreeju M p  old age homes  saketham charitable trust, Vyllongara, angadippuram P O
Malappuram
KERALA 		 9747165845

sreejump93@gmail.com 
Sreeju M p  salva care home  moorippadam, valluvangad P O pandikkad
Malappuram
KERALA 		 9747165845

sreejump93@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
abhayam  Approved 
Institutional Ethics Committee  Approved 
saketam old home  Approved 
salvacare home  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F321||Major depressive disorder, singleepisode, moderate. Ayurveda Condition: VISHADAH/DINATA (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: aswagandha churna, Reference: classical, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: warm water), Additional Information: yoga - 45 minutes loosening exercises- Grīvāsitilīkaraṇā Skanḍasitilīkaraṇā Katisanćālanā Jānusaćālanā Pādasanćālanā - 10 minutes asanas -Tādāsanā Katisaktivikāsanā Mārjāri āsanā Bujangāsanā Ardhasalabāsanā Pavanamuktāsanā Ardhachkrāsana - 15 minutes pranayama - Sūryānulomanā Nādisuddi Bastrikā Brāmari Kapalabāti - 10 minutes relaxation -
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1 Diagnosed cases of mild to moderate geriatric depression as per ICD-10
2 GDS Score 5-11
3 Age group 65 – 80 years
4 Those willing to give written consent
5 No discrimination sex & religion
• Those fit for the yoga module
 
 
ExclusionCriteria 
Details  • Uncontrolled DM, hypertension and thyroid dysfunction
• Diagnosed cases liver or kidney dysfunction, significant lung diseases, congestive heart failure, IHD
• Having major surgery in last one year or planning to undergo surgeries in next 6 months
• Any other comorbid psychiatric conditions.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To assess the effect of Aśvagandha cūrṇa along with selected yoga module in mild to moderate geriatric depression using geriatric depression scale
 		 15th day, 30th day, 45th day 
 
Secondary Outcome  
Outcome  TimePoints 
to assess the quality of life of participants in mild to moderate geriatric depression   30th day, 45 th day 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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 3 
Date of First Enrollment (India)   15/12/2022 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Geriatric depression is a mental and emotional disorder which affects  older adults. Age itself is not a risk for the development of depression, but being widowed and having chronic medical illness are associated with vulnerability to depressive disorders. Late life of depression is characterized by high rates of recurrence. Common signs and symptoms of depressive disorders include reduced energy and concentration, sleep problems, reduced appetite, weight loss and somatic complaints.

Antidepressants are the major choice of treatment, which may cause undesirable                            side  effects. Extract of Aswagandha is being widely used in the treatment of depression and anxiety. Scientific research data of its churna form is unavailable. Yoga also has significant effect in improving well-being, mood, mobility and cognition.  Hence the study include intake of Asvagandha cÅ«rṇa and selected yoga module.

Thirty-two participants which satisfies the inclusion criteria will be selected from old age homes located in Malappuram, Palakkad and Kozhikode, by following the method of proportionate stratified sampling. 3 gram  AÅ›vagandha cÅ«rṇa    with luke warm water will be given  to each participant twice a day after food and 45 minutes yoga module  for 30 days. Assessment will be done before treatment, 15 th day,31 st day, and 46 th day with geriatric depression scale and quality of life using life satisfaction index- A before treatment,31 st day and 46 th day. Data will be statistically analyzed using appropriate tests and will be presented in the form of dissertation.

 

Key words: Geriatric depression, Asvagandha cūrṇa, yoga

 
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