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CTRI Number  CTRI/2021/12/038595 [Registered on: 13/12/2021] Trial Registered Prospectively
Last Modified On: 11/12/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The Role of Saraswata Churna and Ashwagandha Ghrita in the management of depressive disorder (Undmada) 
Scientific Title of Study   An Open Randomized Control Clinical study on efficacy of Saraswata Churna and Ashwagandha Ghrita in the management of Kaphaja Unmada w.s.r. depressive disorders  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vaidya Sandeep Aggarwal 
Designation  Phd Scholar 
Affiliation  Shri Krishna AYUSH University  
Address  Room No 55 56 Ground Floor Department of Kayachikitsa Shri Krishna AYUSH University Kurukshetra Haryana

Kurukshetra
HARYANA
136118
India 
Phone  9319577700  
Fax    
Email  dhanwantri211@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Balbir Singh Sandhu 
Designation  Professor 
Affiliation  Shri Krishna AYUSH University  
Address  Room No 55 56 Ground Floor Department of Kayachikitsa Shri Krishna AYUSH University Kurukshetra Haryana

Kurukshetra
HARYANA
136118
India 
Phone  9813063424  
Fax    
Email  balbirsandhu63@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prof Balbir Singh Sandhu 
Designation  Professor 
Affiliation  Shri Krishna AYUSH University  
Address  Room No 55 56 Ground Floor Department of Kayachikitsa Shri Krishna AYUSH University Kurukshetra Haryana


HARYANA
136118
India 
Phone  9813063424  
Fax    
Email  balbirsandhu63@gmail.com  
 
Source of Monetary or Material Support  
Shri Krishna AYUSH University Kurukshetra Haryana 
 
Primary Sponsor  
Name  Shri Krishna AYUSH University  
Address  Ground Floor Department of Kayachikitsa Shri Krishna AYUSH University Kurukshetra Haryana 
Type of Sponsor  Government medical college 
 
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 
Sandeep Aggarwal  Shri Krishna AYUSH University  Ground Floor Department of Kayachikitsa Shri Krishna AYUSH University Kurukshetra Haryana
Kurukshetra
HARYANA 
9319577700

dhanwantri211@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F330||Major depressive disorder, recurrent, mild. Ayurveda Condition: KAPHAJA UNMADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Saraswata Churna, Reference: Bhaishjya Ratnawali 26,27,28,29 pg. no. 513, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Madhu & Ghrita), Additional Information:
2Comparator ArmDrugClassical(1) Medicine Name: Ashwagandha Ghrita, Reference: Bhaishajaya Ratnavali 26 Adhyaya Vatavyadhi Chikitsa 26/220, Route: Oral, Dosage Form: Ghrita, Dose: 6(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Sukhoushna Jala (Lukewarm water)), Additional Information:
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1 Age groups 30-75 years of either sex, no discrimination of caste and religion

2 Hamilton’s Depression Rating Scale and Ayurvedic Assessment Scale in Kaphaja Unmada
diagnostic criteria for mood disorder due to general medical Condition of Unmada with
depressive features. 
 
ExclusionCriteria 
Details  1 Patient with a history of hereditary or previous mental disorders
2 Unconscious & coma patients
3 Intracranial infections such as Meningitis
4 Space occupying lesions of the brain such as tumours
5 Stroke due to RTA, Traumas
6 Congenital defects- diffuse sclerosis, cerebral agenesis, etc. & other major illness
7 Events promoting depression other than the impact of Kaphaja Unmada
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To rule out the significant result of Saraswata Churna and Ashwagandha Ghrita in the management of Kaphaja Unmada w.s.r. depressive disorders  8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To rule out the significant result of Saraswata Churna in the management of Kaphaja Unmada w.s.r. depressive disorders  8 weeks 
To rule out the significant result of Ashwagandha Ghrita in the management of Kaphaja Unmada w.s.r. depressive disorders  8 weeks 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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   N/A 
Date of First Enrollment (India)   13/12/2021 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   BRIEF SUMMARY ON PURPOSE - 

Kaphaja Unmada is a common cause of depression in today’s era. Unmada further deceives the eligibility for the patient to become normal in his life. This event not only changes the patient but its environment leading to harm at Social, Physiological & at Physical levels. Contemporary science focuses on the suppression of depression but comparatively,  Ayurveda focuses on treating the cause. So, it is a humble effort to manage Unmada through Ayurveda by conducting this clinical trial for the betterment of human beings.

BACKGROUND OF TRIAL- it is an interventional  Study

Randomized Patients with a written consent form for the study will be selected. The  Patients will be divided into three groups (irrespective of Gender, Cast, Religion,) in Group A - 40 and Group B – 40, Group c – 40). To Assess the Efficacy of Sleep in Group A (Saraswati Churna) and Group B ( Ashwagandha Ghrita) and Group C (Both Saraswati Churna + Ashwagandha Ghrita)  Randomly selected Patients with the help of hamilton’s Depression Rating Scale and Ayurvedic Assessment Scale in Kaphaja Unmada diagnostic criteria will be taken. The Patients were advised for 4 gm Saraswata Churna with Madhu / Ghrita and  Ashwagandha Ghrita 3-6 ml with lukewarm water were collected for a period of 2 months (60 days). After all these procedures follow up will be taken and an Assessment is done with the help of hamilton’s Depression Rating Scale and Ayurvedic Assessment Scale in Kaphaja Unmada diagnostic criteria.

Finding - There will be a Significant effect of Saraswata Churna and Ashwagandha Ghrita in the management of Kaphaja Unmada w.s.r. depressive disorders”

 
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