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
|
|
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 “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 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)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. |