Effective treatment for Depression without any adverse effects

Phase 2/3

Recruiting

Conditions: Major depressive disorder, singleepisode, mild. Ayurveda Condition: UNMADAH,

Registration Number: CTRI/2022/12/048026

Lead Sponsor: Dr D Y Patil College of Ayurved and Research Centre Pimpri Pune

Brief Summary: 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 personâ€™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 â€” 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 â€œUnmadaâ€ 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 (Cowâ€™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)

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 40

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
to assess the effect of Panchagavya GhritaPaana and Pratimarsha Nasya in the management of Kaphaja Unmada	30 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1): BVVS Ayurved Medical College &Hospit Bagalkot Karnataka
🇮🇳
Bagalkot, KARNATAKA, India
BVVS Ayurved Medical College &Hospit Bagalkot Karnataka
🇮🇳Bagalkot, KARNATAKA, India
Dr Sunilkumar M Chabanur
Principal investigator
9740878703
drsunilkumar09@gmail.com