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CTRI Number  CTRI/2024/07/070417 [Registered on: 10/07/2024] Trial Registered Prospectively
Last Modified On: 09/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Ayurvedic management of Kaphaja Unmada (Depressive disorders) 
Scientific Title of Study   An exploratory single arm study on the efficacy of siddharthak agada vati and purana ghrita nasya in the management of Kaphaja unmada (depressive disorders) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kiran Kamaliya 
Designation  MD Scholar 
Affiliation  Post Graduate Institute Of Ayurved Jodhpur Rajasthan 
Address  PG Department Of Agad Tantra Post Graduate Institute Of Ayurved Dr S R Rajasthan Ayurved University Jodhpur Rajasthan Jodhpur RAJASTHAN India Jodhpur RAJASTHAN 342037 India

Jodhpur
RAJASTHAN
342037
India 
Phone  9904063989  
Fax    
Email  kirankamaliya0107@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ritu Kapoor 
Designation  professor 
Affiliation  Post Graduate Institute Of Ayurved Jodhpur Rajasthan 
Address  PG Department Of Agad Tantra Post Graduate Institute Of Ayurved Dr S R Rajasthan Ayurved University Jodhpur Rajasthan Jodhpur RAJASTHAN India Jodhpur RAJASTHAN 342037 India

Jodhpur
RAJASTHAN
342037
India 
Phone  9529831215  
Fax    
Email  drritukapoor4@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ritu Kapoor 
Designation  professor 
Affiliation  Post Graduate Institute Of Ayurved Jodhpur Rajasthan 
Address  PG Department Of Agad Tantra Post Graduate Institute Of Ayurved Dr S R Rajasthan Ayurved University Jodhpur Rajasthan Jodhpur RAJASTHAN India Jodhpur RAJASTHAN 342037 India


RAJASTHAN
342037
India 
Phone  9529831215  
Fax    
Email  drritukapoor4@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute Of Ayurved Jodhpur 342037 
 
Primary Sponsor  
Name  Post Graduate Institute of Ayurved Jodhpur 
Address  PG Department of Agad Tantra Post Graduate Institute of Ayurved jodhpur 342037 
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 
Dr Kiran kamaliya  Post Graduate Institute of Ayurved Jodhpur  PG department of Agad tantra Post graduate institute of ayurved jodhpur 342037 Jodhpur RAJASTHAN
Jodhpur
RAJASTHAN 		 9904063989

kirankamaliya0107@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur Post Graduate Institute of Ayurved Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F331||Major depressive disorder, recurrent, moderate. Ayurveda Condition: MANOVAHASROTOVIKARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Bhavprakash, Purvakhanda, Procedure details: Twice a day )
(1) Medicine Name: Purana Ghrita , Reference: Bhavprakash, Purvakhanda, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: bd, Duration: 45 Days
2Intervention ArmDrugClassical(1) Medicine Name: Siddharthak Agada , Reference: Charaka Samhita, Chikitsa Sthan, Route: Oral, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 500(mg), Frequency: tds, Bhaishajya Kal: 45 Days, Duration: , anupAna/sahapAna: No, Additional Information:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Patients diagnosed as per the criteria for mild and moderate depression as per ICD10.
Subject who had mild and moderate major depressive disorder and must had
minimum total score of 14 and maximum of 28 on the 21 items of BDI (Beck
Depression Inventory) score at baseline visit.
Patients between the age group of 18 Years–45Years.
Patients of either gender, irrespective of socioeconomic.
Subject willing to follow the procedures as per the study protocol and voluntarily
signed and informed consent form. 
 
ExclusionCriteria 
Details  Patients with other psychiatric disorders like schizophrenia, bipolar mood disorders and
substance abuse.
Patients with severe depressive disorders.
Suicidal ideation
Patients with other systemic disorders like uncontrolled hypertension, diabetes mellitus,
tuberculosis.
Pregnant and lactating mothers or planning to become pregnant during the study.
Clinically unfit for therapy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in BDI Score  45 days 
 
Secondary Outcome  
Outcome  TimePoints 
To improve the Quality of Life  45 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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/ Phase 4 
Date of First Enrollment (India)   12/08/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This study is single arm, an open label trial, with single group of 30 patients to assess the efficacy of Siddharthak agada vati and Purana Ghrita Nasya in the management of Kaphaja Unmada. The primary objective of the study is reducing subjective criteria BDI score. drug will be administered with milk after meal in the dosage of 500mg vati orally thrice a day and 2 drops Nasal twice a day before meal. Total duration of the treatment is 45 days followed up once in a week regularly.  

 
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