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“A Study to Evaluate the Efficacy of Shirobasti(Pulling of medicated oil) and Nasya(medicinal nasal drops) With and Without Medicine (Levodopa) in the Management of Kampavata (Parkinson’s Disease).

Phase 2
Completed
Conditions
Extrapyramidal and movement disorders, (2) ICD-10 Condition: G32||Other degenerative disorders of nervous system in diseases classified elsewhere, (3) ICD-10 Condition: G328||Other specified degenerative disorders of nervous system in diseases classified elsewhere, (4) ICD-10 Condition: G328||Other specified degenerative disorders of nervous system in diseases classified elsewhere,
Registration Number
CTRI/2018/08/015533
Lead Sponsor
National Institute of Ayurveda
Brief Summary

Parkinson’s disease (PD) is the most common form of a group of progressive neurodegenerative disorders characterized by bradykinesia, rest tremors, muscular rigidity, shuffling gait and flexed posture. Most of the features match with the Ayurvedic description of *KAMPAVATA*. Worldwide incidence of PD is estimated to be around 7 to 10 million. *Acharaya Charaka* noted tremors in different organs like head. Various synonyms used are “*Kampanaâ€, “Vepanaâ€, “Vepathuâ€,* and *“Spandana*†all indicating tremors of varying nature and severity. Majority of symptoms of *Kampavata* are mentioned in different *Avaranas, Charaka* says that *Avarana* of *Vyana and Udana* by *Kapha* produces symptoms like *Gatisanga, Vakswaragraha, Gurugatrata, Stambana* and *Kampana*. *Panchkarma* procedures are especially advocated in the treatment of neurological diseases. Different types of *Snehana, Swedana* are efficacious. Besides a special treatment like *Shirobasti, Shirodhara, Nasya and Basti* *karma* are indicated in such diseases. Among the management of *Vata vyadhis* very less work has been carried out in management of *Kampavata*. Most of the *Vata vyadhis* are not curable but the patient may be able to live with the diseases with certain degree of inconvenience and difficulties as long as he or she lives. Thus an effort is made to evaluate the synergetic effect of *Shirobasti* and *Nasya* in *Kampavata/*PD.

In the presentstudy the patients will be selected from OPD & IPD of NIA, Jaipur (Raj.), SS Bombaywala-NIA City Hospital, Jaipur (Raj.) and SMS Hospital, Department of Neurology, Jaipur (Raj.). Minimum 30 patients of either sex who fulfill the inclusion criteria or diagnosed cases will be included in the study and cases registered for the study will be divided into two groups, having 15 cases in each group.In  group A patient those receiving Levodopa in fixed dose will be undergone Shirobasti and Nasya with Ksheerbala Taila for 14 days. In group B patient those not taking Levodopa  will be undergone Shirobasti and Nasya with Ksheerbala Taila for 14 days. ***Shirobasti-***The oil is poured on to the head is allowed to remain there for certain period, and this procedure of *Murdha Taila* is called as *Shirobasti*. To be more precise, a special hat, preferably made of leather is fixed around the head just above the ear and eyebrow, and the joint between the head and hat is made leak proof. On to this positioned hat lukewarm oil is poured, and then is allowed to remain there for about 45-50 minutes (53 minutes in case of *vataja vikaras*, 43 minutes in *pittaja vikaras* and 31 minutes in case of *kaphaja vikaras*). This therapeutic procedure of *Bhaya sneha* to the head is referred as *Shirobasti.* This is then followed by *Shiro-abhyanga*.  ***Nasya -***After *Abhyanga* and *Svedana* of *Uttamanga*, *Nasya* with *Ksheerbala* *Taila* is administered with the help of dropper, 8 (eight) drops to each nostril.

**TRIAL DRUG –***Ksheerbala Taila* **f**or *Shirobasti* and *Nasya* both.The Subjective and objective parameters of base line data to post procedural data will be compared for assessment on the basis of UPDRS scale (Unified Parkinson Disease Rating Scale) (modified) before and after the treatment. All the results will be analyzed statistically.

**CONCLUSION:**The present study has been entitled as “An Open Clinical Study to Evaluate the Efficacy of *Shirobasti* and *Nasya* With and Without Levodopa in the Management of *Kampavata* w.s.r. to Parkinson’s disease (PD)â€. Based on the literature and observations made in this clinical study, following conclusions can be drawn. *Kampavata* bears a resemblance to the clinical features of Parkinson’s disease (PD).   *Kampavata* being a *Vata* *Vyadhi*, *Brihmana* is best suitable therapy and both *Shirobasti* and *Tarpana* *Nasya* are best recommended in reducing stress in the patients of *Kampavata* (PD) as both the procedures are non-invasive, outpatient procedures with minimal discomfort.

Observations and results of the present study holds the explanation of the Modern and Ayurveda literatures and also supports the results of the previous work done.Specific etiology was not found in any of the patients considered for the present study but *Mansika* *Hetu* was found in most of the patients. Maximum results were found in Mentation, Behaviour and mood of UPDRS scale. The comparative effect of both the procedures showed more significant results in Group B (without levodopa) than Group A (with levodopa).

In Group A, significant results were found in *Stambha, Gativikriti, Avanamana,* ADL, Motor Examination, Schwab and England ADL scale and in Group B, significant results were found in *Kampa, Chestasanga, Vakavikriti*, Mentation, Behaviour and mood, Modified Hoehn and Yahr Staging.

Therefore, it can be concluded that the *Shirobasti* and *Nasya* show improvement in the signs and symptoms of Kampavata (PD) in both the groups. Both the procedures are efficacious in reducing Activities of Daily Living, thereby improving quality of life.

**Suggestions for further studies;**

1.       Study on large samples.

2.       Study of both the procedures repeatedly in a year for 3-4 times.

3.       Standardization of both the procedures in the patients of *Kampavata* (PD).

4.       Study in the management of *Kampavata* (PD) with other Panchkarma procedures.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
30
Inclusion Criteria
  • 1.Patients between 40-70 years of age.
  • 2.Patients with clinical signs and symptoms of Kampavata/ PD.
  • 3.Patients of either sex irrespective of their occupation, religion and socio-economic status.
  • 4.Patients of kampavata/PD who are on a fixed dose of levodopa and fit for Shirobasti and Nasya.
  • 5.Patients of kampavata/PD who are not on levodopa and fit for Shirobasti and Nasya.
  • 6.Patients willing to participate for interventional study.
Exclusion Criteria
  • 1.Patients with severe systemic disorders as Uncontrolled Hypertension, Cardiac Problem, Diabetes Mellitus, Tuberculosis, Leprosy, Paralysis, malignant disease etc.
  • 2.Patients unfit for Shirobasti and Nasya.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Assessment of changes in specific signs and symptoms of Kampavata/PD.45 days
Secondary Outcome Measures
NameTimeMethod
Any adverse effect in the values of hematological test and in clinical signs and symptoms.45 days

Trial Locations

Locations (1)

PG Department of Panchkarma, OPD Room no 2,National Institute of Ayurveda

🇮🇳

Jaipur, RAJASTHAN, India

PG Department of Panchkarma, OPD Room no 2,National Institute of Ayurveda
🇮🇳Jaipur, RAJASTHAN, India
Dr Jatinder Verma
Principal investigator
9416116378
jatinderverma2312@gmail.com

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