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CTRI Number  CTRI/2022/12/048026 [Registered on: 12/12/2022] Trial Registered Prospectively
Last Modified On: 03/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effective treatment for Depression without any adverse effects 
Scientific Title of Study   “A COMPARATIVE CONTROL CLINICAL STUDY TO EVALUATE THE EFFICACY OF PANCHAGAVYA GHRITAPAANA AND PRATIMARSHA NASYA IN THE MANAGEMENT OF KAPHAJA UNMADA”  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sunilkumar M Chabanur 
Designation  PhD SCHOLAR KAYACHIKITSA 
Affiliation  D. Y. Patil College of Ayurved & Research Centre Pimpri, Pune 411018 
Address  Department of Kayachikitsa Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune 411018
Department of Kayachikitsa Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune 411018
Pune
MAHARASHTRA
411018
India 
Phone  9740878703  
Fax    
Email  drsunilkumar09@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  PROFDR D G DIPANKAR  
Designation  Professor  
Affiliation  D Y Patil College of Ayurved & Research Centre Pimpri, Pune 411018 
Address  Department of Kayachikitsa Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune 411018
Department of Kayachikits D D Y Patil College of Ayurved and Research Centre Pimpri Pune 411018
Pune
MAHARASHTRA
411018
India 
Phone  9822279321  
Fax    
Email  drdgdipankar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  PROFDR D G DIPANKAR  
Designation  Professor  
Affiliation  D Y Patil College of Ayurved & Research Centre Pimpri, Pune 411018 
Address  Department of Kayachikitsa Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune 411018
Department of Kayachikits D D Y Patil College of Ayurved and Research Centre Pimpri Pune 411018

MAHARASHTRA
411018
India 
Phone  9822279321  
Fax    
Email  drdgdipankar@gmail.com  
 
Source of Monetary or Material Support  
Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune 411018  
 
Primary Sponsor  
Name  Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune  
Address  Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune 411018 
Type of Sponsor  Private 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 Sunilkumar M Chabanur  BVVS Ayurved Medical College &Hospit Bagalkot Karnataka  BVVS Ayurved Medical College &Hospital Kayachikitsa department room no 01 Bagalkot Karnataka
Bagalkot
KARNATAKA 
9740878703

drsunilkumar09@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC BVVS Ayurved Medical College and Hospital, Bagalkot, Karnataka  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F320||Major depressive disorder, singleepisode, mild. Ayurveda Condition: UNMADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Sertraline, Reference: text book of medicine, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 50(mg), Frequency: hs, Bhaishajya Kal: Antarabhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Panchagavya Ghrita, Reference: Charaka Samhita Chikitsa sthana !0 chapter, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Warm water), Additional Information: -
3Comparator ArmDrugClassical(1) Medicine Name: Panchagavya Ghrta, Reference: Charaka Chikitsa Sthana 10th chapter, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -warm water), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Patients diagnosed as per the criteria for Kaphaja Unmada and ICD (International Classification of Diseases) 10 Mild to Moderate Depressive disorders.
2. Patients with classical signs and symptoms of Kaphaja Unmada.
3. Patients with classical signs and symptoms of Depression.
 
 
ExclusionCriteria 
Details  1. Patients of other Nijaunmada (Doshaja- Vata,Pitta and Sannipataja) and Bhutajonmada..
2. Diagnosed case of Schizophrenia, Schizophreniform Disorder.
3. Patients suffering from any other psychotic disorders.
4. Patients having substance use disorders.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
to assess the effect of Panchagavya GhritaPaana and Pratimarsha Nasya in the management of Kaphaja Unmada  30 days 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the effect of Antidepressant drug Sertraline
and to compare the effcet of both Panchagavya GhritaPaana and Pratimarsha Nasya with contro; group in the management of Kaphaja Unmada 
30 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   20/12/2022 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Published 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Depression is a disorder of major public health importance, in terms of its prevalence, suffering, dysfunction, morbidity, and economic burden. Depression is more common in women than men. The report on Global Burden of Disease estimates the point prevalence of unipolar depressive episodes to be 1.9% for men and 3.2% for women, and the one-year prevalence has been estimated to be 5.8% for men and 9.5% for women. It is estimated that by the year 2020 if current trends for demographic and epidemiological transition continue, the burden of depression will increase to 5.7% of the total burden of disease and it would be the second leading cause of disability-adjusted life years (DALYs), second only to ischemic heart disease.

 A prevalence of 15.9% for depression was reported by a methodologically rigorous, large sample study, which is quite similar to the Western figures.Indian youth has been reported to have several-fold higher rates for suicide than the global average, and depression is one of the well-known risk factors for suicidal attempts and completed suicides. In India, more than one lakh persons commit suicide/year which, to a certain extent, may be potentially preventable. Studies done specifically in primary health care or medical settings in India have found depression in 21% to as high as 84% of the cases. 

Depression is a common and serious medical illness that negatively affects how you feel the way you think and how you act. Fortunately, it is also treatable. Depression causes feelings of sadness and/or a loss of interest in activities once enjoyed. It can lead to a variety of emotional and physical problems and can decrease a person’s ability to function at work and at home.

The common signs and symptoms of Depression are Feeling sad or having a depressed mood, Loss of interest or pleasure in activities once enjoyed,  Changes in appetite — weight loss or gain unrelated to dieting, Trouble sleeping or sleeping too much, Loss of energy or increased fatigue, Increase in purposeless physical activity (e.g., hand-wringing or pacing) or slowed movements and speech (actions observable by others),Feeling worthless or guilty, Difficulty thinking, concentrating or making decisions, Thoughts of death or suicide.

Bhootavidya is one of the eight speciality branches in Ayurveda. The functions of the mind with its abnormalities have been EFFICACYi discussed in this Ancient science. Many a disease explained in modern psychiatry are well discussed under the umberella term “Unmada” in Ayurveda. The various psychiatric problems have been approached with not only medicine, but also scientific procedures like counselling and psychotherapy.

In Ayurveda Unmada is a common entity which represents many of the psychiatric disorders. In this ailment the intellect, mind, behaviour, memory etc get perverted. Nija unmada (Doshaja) can be applied to the disordered state of mind in which the individual looses the power of regulating his/her actions and conduct according to the rules of the society in which he/she is moving. Kaphajaunmada is one among the Nijaunmada (Doshaja).

 The samanya kaphaja unmade lakshanas are Sthanamekadeshe (staying in one place/decreased motor activities), Tushnibhava (keeping silence/poverty of speech), Alpashaschankramana(reduced motor activity),Sadana (fatigue), Anannabhilasha (disinclination for food),Alpabhuk (less appetite), Rahaskamata (prefer or love for solitude), Bhibhatsyatva (disgust feeling), Shauchadvesha (aversion for cleanliness), Svapnanityata (hypersomnia), Shvayathuranane (edematous face), Chardi (vomiting) and Alpamati (less intellectual activity)

         Panchagavya ghrita is mentioned in Apasmara chikitsa. It is one of the commonly used yogas for Apasmara and Unmada.The combination contains 5 ingredients. Goshakrit (Cow dung) ,Godadhi (Curd),Goksheera (Milk),Gomootra (Cow’s urine) , Goghrit (Ghee) All the drugs are taken in equal quantities and the Ghrit is prepared as per the common preparatory techniques regarding Ghrit. Kaphaja Unmada can be correlated with Depressive Disorder in Modern science. In the control group modern Antidepressant drug Sertraline with 50mg OD at night will be given which belongs to a group of Selective Serotonin Reuptake Inhibitor (SSRI)

 
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