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CLINICAL RESEARCH
Year : 2010  |  Volume : 31  |  Issue : 2  |  Page : 205-209 Table of Contents     

A comparative clinical trial on the role of Panchakarma therapy and Unmada Gajankusha Rasa in the cases of major depressive disorder vis-à-vis kaphaja Unmada


1 Division of Manasa Chikitsa, Department of Kayachikitsa, Institute of Medical Sciences,Banaras Hindu University, Varanasi, India
2 Department of Psychiatry, Institute of Medical Sciences,Banaras Hindu University, Varanasi, India
3 Department of Ayurvedic Pharmacy, Institute of Medical Sciences,Banaras Hindu University, Varanasi, India

Date of Web Publication10-Nov-2010

Correspondence Address:
J S Tripathi
Associate Professor & Incharge, Division of Manas Chikitsa(Psychosomatic Medicine & Psychiatry), Department of Kayachikitsa, Faculty of Ayurveda, I.M.S., B.H.U., Varanasi
India
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DOI: 10.4103/0974-8520.72396

PMID: 22131711

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   Abstract 

Depression is a common but serious mood disorder which exerts wide range of physical, physiological and psychological impact. On the basis of the severity of disease, depression is classified under various categories. Of all the types of depression, major depressive disorder resembles the features of kaphaja Unmada. The patients of Kaphaja Unmada are dirty in appearance, their speech and activities are retarded and they prefer to remain in solitude and lonely places. The present study has been conducted in eighty patients of major depressive disorder dividing them into four groups, A, B, C and D using Vamana therapy and Unmada Gajankusha Rasa in the dose of 250 mg twice daily with water. The results were assessed on scoring of clinical symptoms and signs and by using Hamilton depression rating scale (HDRS).The results reveal the mild to moderate degree of response over various parameters which has been presented in detail in the article.

Keywords: Kaphaja Unmada, major depressive disorder , Panchakarma, Unmada Gajankusha Rasa Vamana karma.


How to cite this article:
Dubey S, Tripathi J S, Gupta S, Reddy K. A comparative clinical trial on the role of Panchakarma therapy and Unmada Gajankusha Rasa in the cases of major depressive disorder vis-à-vis kaphaja Unmada. AYU 2010;31:205-9

How to cite this URL:
Dubey S, Tripathi J S, Gupta S, Reddy K. A comparative clinical trial on the role of Panchakarma therapy and Unmada Gajankusha Rasa in the cases of major depressive disorder vis-à-vis kaphaja Unmada. AYU [serial online] 2010 [cited 2014 Nov 1];31:205-9. Available from: http://www.ayujournal.org/text.asp?2010/31/2/205/72396


   Introduction Top


Everyone occasionally feels blue or sad, but these feelings are usually fleeting and pass within a couple of days. When a person has a depressive disorder, it interferes with daily life, normal functioning, and causes pain for both the person with the disorder and those who care about him or her. Depression is a common but serious illness, and anyone who experiences it need treatment to get better. Major depression is defined as depressed mood on a daily basis for a minimum duration of two weeks. An episode may be characterized by sadness, indifference, apathy, or irritability and is usually associated with changes in sleep patterns, appetite, and weight; motor agitation or retardation; fatigue; impaired concentration and decision-making; feelings of shame or guilt; and thoughts of death or dying. Patients with depression have a profound loss of pleasure in all enjoyable activities, exhibit early morning awakening, feel that the dysphoric mood state is qualitatively different from sadness, and often notice a diurnal variation in mood (worse in morning hours). [1] According to Aacharya Charaka, the patients of Kaphaja Unmada are dirty in appearance, their speech and activities are retarded and they prefer to remain in solitude and lonely places. Their biological functions like sleep, sex desire and appetite grossly disturbed. They like complete silence and show disinterest in taking food. Dribbling of saliva from mouth along with whitish discoloration of eyes and nails are commonly found. [2] All these features support the Kaphaja Unmada as full blown depressive disease described as major depressive disorder.

Despite all the developments with regard to the management of depression and the world wide researches, a satisfactory management of depression is still elusive. Though, many modern medications are available but they are not free of adverse effects. Further, their effects are also not sustained for long time unless the real cause of the disease is not rooted out.


   Aims and Objectives Top


The present study was planned with the objectives of assessing the effect of Vamana therapy and the role of Unmada Gajankusha Rasa in the management of the major depressive disorder and to compare their antidepressant activity clinically with established modern antidepressant fluoxetine. It was also planned to study the combined effect of trial therapy and medication in a separate group of patients.


   Materials and Methods Top


Selection of cases

Eighty cases, recruited under the present study, were selected from the Kayachikitsa O.P.D., I.P.D. and Department of Psychiatry O.P.D., S.S.Hospital, I.M.S., B.H.U. Varanasi. Case selection was random regardless of age, sex, occupation and socioeconomic considerations.

Inclusion criteria

The patients who fulfilled the DSM-IV diagnostic criteria for major depressive disorder were included in this study and were subjected to clinical trial of Unmada Gajankusha Rasa and Vamana therapy. Patients having severely depressed mood, markedly diminished interest or pleasure, psychomotor retardation, worthlessness, recurrent thoughts of death diminished social and occupational functions for at least two weeks and conforming to the DSM-IV criteria were included in the present study.

The exclusion criteria

Patients with symptoms or having the history of following clinical conditions were excluded

  1. Mood incongruent delusions or hallucinations, incoherence, marked loosening of associations.
  2. Superimposed schizophrenia, schizophreniform disorders, mania or bipolar disorders.
  3. Generalized anxiety disorders, obsessive compulsive disorders.
  4. Chronic drug abuse, e.g.-barbiturates, etc.
  5. Toxic abuse like alcohol ingestion and withdrawal.
  6. Organic diseases like some diseases of gastrointestinal system (irritable bowel syndrome, colitis), myocardial infarction, CNS disease (e.g. Alzheimer's disease), metabolic and endocrine disorders (e.g. hypothyroidism, hypoglycemia) and systemic diseases like rheumatoid arthritis and other connective tissue disorders etc were excluded from the study. Relevant investigations were done, wherever found necessary.


Study groups

All the patients who were selected for the study, after carefully examining their clinical presentation and fulfilling the inclusion criteria, were registered for this study. Eighty patients, who turned up for complete follow-ups, were belonging to four groups as follows:

  1. The first group (n = 10) patients were given Vamana therapy.
  2. The second group (n = 30) patients were put on the trial drug Unmada Gajankusha Rasa (250 mg) twice a day with plain water for three months.
  3. The third group (n=10) patients were put on Unmada Gajankusha Rasa along with Vamana therapy.
  4. The fourth group (n=30) patients were put on Fluoxetine.20 mg once a day for three months for comparative study.


Follow up study

After the initial registration and basal study, all the patients were recruited in respective trial groups and received the treatment regularly. They were advised to come at 15 days interval for the assessment of progress but the follow ups were recorded each at one month interval for three consecutive months. During each visit, patients were interviewed regarding their progress in symptomatology, physical examination, mental status examination, if any or other associated features besides informations about compliance of the therapy given. Proper records were taken.

Parameters for assessment of the therapeutic response

  1. Clinical assessment
  2. Psychological assessment


Clinical assessment

The symptomatic relief produced by the trial treatment was assessed by subjective analysis converted into objective scoring of symptoms during initial visit and on successive follow ups at one month intervals for entire period of therapeutic trial i.e. for three months.

Psychological assessment

The effect of treatment was also assessed in terms of certain psychological factors. The emphasis was put to the rating of changes in the scores of depression. Hamilton depression rating scale (HDRS) has been used to quantify the psychological parameters. HDRS is an objective method for clinical assessment of depressive states in patients of depression. Being one of the most reliable scales for measuring level of depression comprising the rating of diverse clinical signs and symptoms of disease, it has been used for the objective assessment of clinical condition in patients of depression in the present study. This scale consists of 17 items, each of which is rated from 0 to 2 or 0 to 4 with total scoring ranging from 0 to 50. Score of 7 or less may be considered as normal, 8 to 13 mild, 14-18 moderate, 19-22 severe and 23 and above very serious depression.

Statistical test

The obtained data on the basis of observations was subjected to statistical analysis in terms of mean, standard deviation, and standard error by applying paired and unpaired't' test. The results were interpreted at the level of P<0.001 as highly significant, P<0.05 or P<0.01 as significant and P<0.10 or P>0.01 as insignificant.

Trial drug

Unmada Gajankusha Rasa is mentioned in various authentic text books of ΐyurveda . In the present work, Unmada Gajankusha Rasa has been used for clinical trial as per the reference of Bhaishajya Ratnavali. It was prepared in ΐyurvedic pharmacy, I.M.S., B.H.U adopting the method of preparation mentioned in classics. It contains Parada (mercury), Dhattura mula (roots of Datura metel), Shuddha Vishamushti (Strychnos nuxvomica), Tamra churna (copper), Suddha Gandhaka (pure sulfur), Suddha Dhattura Bija (seeds of Dhatura metel), Abhraka bhasma and Shuddha Vatsanabha (Aconitum ferox).The drug was administered in the doses of 250mg twice a day with plain water for three months. [3]

Vamana therapy

Vamana or therapeutic emesis is the procedure of eliminating Kapha dosha from the body through the upper passages by vomiting. Emesis therapy is not merely a matter of administration of emetics to empty the contents of the chest and G.I.T. but according to ΐyurvedic principles, it is a therapeutic measure to be applied after the patient has been prepared properly by snehana with the help of Abhyantara ghritapan for specific period of (Accha ghιta in present study) five to seven days and Bahya snehana (Abhyanga) with Mahanarayana taila and Swedana (fomentation) for total biological purification of the body. Vamana was given with the following drugs: Madana phala Churna -8 g, Yashtimadhu Churna-10 g., Vacha Churna-4 g, Saindhava lavana-25 g.-50 g, Honey - 50 ml, Milk - 4-5 l.


   Results Top


The effect of therapy in Groups A, B, C, and D is shown in Graphs 1, 2, 3, and 4 respectively[Additional file 1][Additional file 2][Additional file 3][Additional file 4]. The statistical comparison between the groups is shown in [Table 1] below.
Table 1 :Inter group comparison on the basis of Hamilton depression rating scale (HDRS) scores

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   Discussion Top


The pre and post treatment observations were recorded and the paired 't' test was done to find out the statistical significance. Regarding the response of the treatment on symptoms in the patients of Group A, treated with Vamana therapy, it was found that there was highly significant response in case of disturbed sleep, which may be because Vamana eradicates Tridosha in general and particularly kapha dosha (Cha.Su.15/22). Vata controls and regulates Mana (Cha Su.-12/4(5)), optimum psychosomatic state is responsible for proper sleep pattern and its physiology. Samshodhana has its beneficial psychosomatic effect (Cha.Chi.9/28); therefore, it can be said that Vamana would be an excellent treatment in depressive illness being predominantly a Kaphaja disorder. Aruchi is nanatmaja vyadhi of Kapha (Cha.Su.20/17), Vamana is responsible for significant improvement in Aruchi (Anorexia with weight loss), Ruja (pain) is due to Vata, Vamana eradicates Vata also due to its quality to pacify Tridosha (Cha.Su.15/22). It has provided highly significant improvement in bodyache. Headache (Shiroruja) is due to Tridosha and as Vamana eradicates Tridosha, this quality is responsible for highly significant improvement in headache. Easy fatigability (Klama) is due to Kapha, Vamana is the best procedure to eradicate the Kapha consequently gives highly significant result in easy fatigue. Loss of interest in activities is also due to excess of Kapha, probably this is the reason why highly significant result has been achieved in case of loss of interest in activities. Lack of confidence is very much related to mental status; it is the feature of hina satva, Vamana improves Bala (Cha.Su.15/22), it can be the reason behind highly significant improvement in case of lack of confidence. Irritability (Anvasthitcittata) is the (Cha.Su-20/11) Vamana as stated earlier eradicates Vata also; in this study, highly significant improvement has also been obtained in case of irritability. Unexplained fear and suicidal ideation indicate lack of Bala to cope up his/her problem, as stated earlier Vamana improves Bala; which may be responsible for highly significant improvement in suicidal ideas. Sad mood and psychomotor retardation are Kaphaja features, so Vamana may have produced highly significant improvement due to its property. Impaired concentration and forgetfulness has thereby shown significant improvement, it may be due to improvement of mental functioning by Vamana. (…..Manaha prasadama Apnoti smritim sanjnama cha vindati -Cha.Chi.9/28).

In Group-B patients , treated with Unmada Gajankusha Rasa alone, highly significant changes were found in disturbed sleep, bodyache, headache, easy fatiguability, loss of interest in activities, lack of confidence, irritability, unexplained fear, sad mood and significant changes were found in impaired concentration and forgetfulness. Unmada Gajankusha Rasa is a herbomineral preparation containing certain Vishaushadhis like Aconitum ferox, Datura metel, Strychnos nuxvomica having Ushna Veerya property and in their medicinal doses, pacify Vata and Kapha Doshas. Murcchita Parada with Gandhaka (sulfur) has Vyadhinashaka property, Abhraka pacify Tridosha, Tamra has the property to pacify Kapha and Pitta. In the light of these pharmacological properties, it can be said that Unmada Gajankusha Rasa provides the beneficial psychotropic effect in major depressive disorder vis-a-vis Kaphaja Unmada.

In the patients of Group C , treated by the combination of Vamana therapy and Unmada Gajankusha Rasa, statistically highly significant changes were observed in disturbed sleep, bodyache, easy fatiguability, loss interest in activities, lack of confidence, impaired concentration and forgetfulness, suicidal ideation and significant changes were found in Anorexia with weight loss, headache, unexplained fear, sad mood, and psychomotor retardation.

As discussed earlier, Vamana and trial drug have significant and highly significant effect symptomatically in the cases of major depressive disorder vis-a-vis Kaphaja Unmada, might have produced synergistic effect, which is evident from relatively better clinical effect when used in combination.

Therapeutic response was also objectively assessed with the help of rating on HDRS. In HDRS, statistically highly significant results were found in the items of depressed mood, work interest, retardation, while significant findings were obtained in suicide, insomnia initial and insomnia delayed somatic general and loss of weight. In case of Group A, in which the patients were given Vamana therapy, which is supposed to be the best procedure to eradicate the Kapha. In Group B patients, statistically highly significant changes were found in suicide, insomnia initial, work interest, retardation, somatic general while significant result was found in case of agitation.

Trial drug, Unmada Gajankusha Rasa, specially has the property to pacify specially the Vata, Kapha dosha which has been used in this group of patients.

In Group C patients, statistically highly significant changes were found in depressed mood, guilt, suicide, insomnia initial, retardation, loss of weight, while significant changes were found in work interest and somatic general. Vamana along with trial drug was used in these patients.

On comparison between Groups B and C and A and D in terms of HDRS score, statistically highly significant changes were observed, but mean decrease of HDRS score in Group C (5.7±2.12) is more than Group B (3.62 ±1.72). The intergroup comparison reveals that it may be due to additional purificatory effect of Vamana thereby in Group C applied which might be responsible for slightly better effect seen in Group C patients.

On comparison between Group A and D, statistically highly significant changes were observed, but mean decrease of HDRS score is more in Group A (10.10 ±3.17) than Group D (5.1±2.7).The difference in effect between Group A and D may be due to the systemic and procedural effect of Vamana therapy which might have resulted in better response than only systemic effect of fluoxetine used in control group to compare the effect.


   Conclusion Top


It may be concluded that Vamana therapy is a very effective procedure in the cases of major depressive disorder and Unmada Gajankusha Rasa is a mild to moderately effective remedy in the cases of major depressive disorder. Therefore, it can be concluded that Vamana and Unmada Gajankusha Rasa both have exerted moderate to mild antidepressant effect. As discussed earlier, Vamana and trial drug have significant and highly significant effect in the cases of major depressive disorder vis-a-vis Kaphaja Unmada, which might have produced synergistic effect, which is evident from relatively better clinical effect when used in combination.

Thus, the present study has yielded many useful information related to therapeutics and pharmaceutics of ΐyurVeda in general and Kaphaja Unmada vis-a- vis major depressive disorder in particular. The findings of this study have the potential to enlighten the future researches in this area and provide lead for future work.

 
   References Top

1.Kaplan, Harold I, Sadock BJ. Synopsis of Psychiatry. 6 th ed. Baltimore, Maryland, U.S.A.: Willium and wilkins; 1991,  Back to cited text no. 1
    
2.Charak samhita, Vol.2, 2 nd ed.,1984, Chaukhambha Bharati Academy, Varanasi; 1984,  Back to cited text no. 2
    
3.Das G, 'Bhaishhjya Ratnavali'. In: Mishra BB, editor. "Vidyotini" Hindi commentary Analysis with appendixes by Shri Kaviraj Ambikadatta Shastri. 18 th ed. Varanasi: Chaukhamba Sanskrit Bhavan; 2005. p. 514,  Back to cited text no. 3
    



 
 
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