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CTRI Number  CTRI/2018/08/015533 [Registered on: 30/08/2018] Trial Registered Prospectively
Last Modified On: 22/06/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Other 
Public Title of Study   “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). 
Scientific Title of Study   “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). 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jatinder Verma 
Designation  MD Scholar 
Affiliation  National Institute of Ayurveda 
Address  PG Department of Panchkarma, National Institute of Ayurveda, Madhav Vilas Palace, Jorahawar Singh gate, Amer road, Jaipur 302002, Rajasthan

Jaipur
RAJASTHAN
302002
India 
Phone  9416116378  
Fax    
Email  jatinderverma2312@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gopesh Mangal 
Designation  Assistant Professor 
Affiliation  National Institute of Ayurveda 
Address  PG Department of Panchkarma, National Institute of Ayurveda, Madhav Vilas Palace, Jorahawar Singh gate, Amer road, Jaipur 302002, Rajasthan

Jaipur
RAJASTHAN
302002
India 
Phone  8619849011  
Fax    
Email  gmangal108@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jatinder Verma 
Designation  MD Scholar 
Affiliation  National Institute of Ayurveda 
Address  PG Department of Panchkarma, National Institute of Ayurveda, Madhav Vilas Palace, Jorahawar Singh gate, Amer road, Jaipur 302002, Rajasthan

Jaipur
RAJASTHAN
302002
India 
Phone  9416116378  
Fax    
Email  jatinderverma2312@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda, Madhav vilas palace, Jorawar Singh Gate, Amer road, Jaipur-302002, Rajasthan 
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  Madhav Vilas Palace, Jorahawar Singh gate, Amer road, Jaipur 302002, Rajasthan 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Dr Jatinder Verma  PG Department of Panchkarma, National Institute of Ayurveda,Madhav Vilas Palace, Jorahawar Singh gate, Amer road, Jaipur 302002, Rajasthan 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jatinder Verma  PG Department of Panchkarma, OPD Room no 2,National Institute of Ayurveda  Madhav Vilas Palace, Jorahawar Singh gate, Amer road, Jaipur 302002, Rajasthan
Jaipur
RAJASTHAN 
9416116378

jatinderverma2312@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, National Institute of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G20-G26||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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A  In this group 15 patient those receiving Levodopa in fixed dose will be undergone Shirobasti and Nasya with Ksheerbala Taila for 14 days. 1. 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. This procedure is repeated for 14 days. 2. Nasya - After Abhyanga and Svedana of Uttamanga, Nasya with Ksheerbala Taila is administered with the help of dropper, 8 (eight) drops to each nostril. Same procedure will be repeated for 14 days.  
Intervention  Group B  In this group 15 patient those who are not taking Levodopa will be undergone Shirobasti and Nasya with Ksheerbala Taila for 14 days.1. 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. This procedure is repeated for 14 days. 2. Nasya - After Abhyanga and Svedana of Uttamanga, Nasya with Ksheerbala Taila is administered with the help of dropper, 8 (eight) drops to each nostril. Same procedure will be repeated for 14 days.  
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details 

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.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Assessment of changes in specific signs and symptoms of Kampavata/PD.   45 days 
 
Secondary Outcome  
Outcome  TimePoints 
Any adverse effect in the values of hematological test and in clinical signs and symptoms.   45 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "27"
Final Enrollment numbers achieved (India)="27" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)
Modification(s)  
04/07/2019 
Date of Study Completion (India) 20/02/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

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 “Kampana”, “Vepana”, “Vepathu”, 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 KampanaPanchkarma 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 present study 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  for 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)”. 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.


 
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