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 UNMADAâ€
|
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
|
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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
|
|
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 |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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Health Type |
Condition |
Patients |
(1) ICD-10 Condition:F320||Major depressive disorder, singleepisode, mild. Ayurveda Condition: UNMADAH, |
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Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Comparator Arm | Drug | Classical | | (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: - | 2 | Comparator Arm | Drug | Classical | | (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: - | 3 | Comparator Arm | Drug | Classical | | (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: - |
|
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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
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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) |