| CTRI Number |
CTRI/2022/06/043053 [Registered on: 07/06/2022] Trial Registered Prospectively |
| Last Modified On: |
10/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate the efficacy of yapana basti(medicated enema) and nasya (nasal drops)along with shirobasti followed by kauncha paka in the management of kampavata with special reference to parkinson’s disease (pd) |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of yapana basti and nasya along with shirobasti followed by kauncha paka in the management of kampavata with special reference 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 Gopesh Mangal |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Room number 116, department of panchakarma, new panchakarma building
madhav vilas palace, joravar singh gate, amer road jaipur,
Jaipur
RAJASTHAN
302002
India |
| Phone |
8619849011 |
| Fax |
|
| Email |
gmangal108@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gopesh Mangal |
| Designation |
Associate professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Room number 116, department of panchakarma, new panchakarma building
madhav vilas palace, joravar singh gate, amer road jaipur,
302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
8619849011 |
| Fax |
|
| Email |
gmangal108@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRaj kumar jha |
| Designation |
M.D.Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
Room number 111, pg seminar hall, department of panchakarma, new panchakarma building
madhav vilas palace, joravar singh gate, amer road jaipur,
Jaipur
RAJASTHAN
302002
India |
| Phone |
8432881200 |
| Fax |
|
| Email |
drrajkumar.jha123@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, Jaipur rajasthan pin code 302002 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Madhav Villas Palace Amer Road Jaipur Rajasthan India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Raj kumar Jha |
National Institute of Ayurveda |
Opd room no 2 and IPD, PG department of Panchakarma,National Institute of Ayurveda Jaipur RAJASTHAN
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN |
8432881200
drrajkumar.jha123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, national institute of ayurveda |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G20||Parkinsons disease. Ayurveda Condition: KAMPAH/VEPATHUH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | SirobastiH, शिरोबसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: ashtang hridayam sutra sthan 22/23, Procedure details: procedure will be porformed as per sop of panchkarma depart. for 16 days.)
(1) Medicine Name: Mashabaladi Taila, Reference: Vata Vyadhi Chikitsa Bhaishjaya Ratnavali 26/551-556, Route: Topical, Dosage Form: Taila, Dose: 800(ml), Frequency: od, Duration: 16 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kauncha Paka, Reference: Yoga Chintamani, , Chapter 1; Bharat Bhaishajya Ratnakara 1/818, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information: -it will be given as shaman aushadh after intervention of both procedure(sirobasti along with basti) | | 3 | Intervention Arm | Procedure | - | yApana-bastiH, यापन-बसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Charaka Siddhi Sthana 12/16(9), Procedure details: the basti procedure will be porformed as sop of panchkarma dept. for 16 days )
(1) Medicine Name: Tritiya Baladi Yapana Basti, Reference: Charaka Siddhi Sthana 12/16(9), Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 500(ml), Frequency: od, Duration: 16 Days | | 4 | Intervention Arm | Procedure | - | SirobastiH, शिरोबसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: ashtang hridayam sutra sthan 22/23, Procedure details: sirobasti will be performed as per sop of the procedure for 16 days.)
(1) Medicine Name: Mashabaladi Taila, Reference: Vata Vyadhi Chikitsa Bhaishjaya Ratnavali 26/551-556, Route: Topical, Dosage Form: Taila, Dose: 800(ml), Frequency: od, Duration: 16 Days | | 5 | Comparator Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: sushruta chikitsa sthan 40/21, Procedure details: procedure will be porformed as per sop of panchakarma dept. for 16 days.)
(1) Medicine Name: Mashabaladi Taila, Reference: Vata Vyadhi Chikitsa Bhaishjaya Ratnavali 26/551-556, Route: Nasal, Dosage Form: Taila, Dose: 6(drops), Frequency: od, Duration: 16 Days | | 6 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kauncha Paka, Reference: Yoga Chintamani, , Chapter 1; Bharat Bhaishajya Ratnakara 1/818, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information: -it will be given as shaman aushadh after both procedure(sirobasti along with nasya) in comparator group |
|
|
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Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
. 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 fit for Shirobasti , Basti and Nasya.
5. Patients willing to participate for interventional study.
|
|
| ExclusionCriteria |
| Details |
. Patients with severe systemic disorders as Uncontrolled Hypertension, Cardiac Problem,
Uncontrolled Diabetes Mellitus, Tuberculosis, Leprosy, Paralysis, malignant disease etc.
2. Patients unfit for Shirobasti , Basti and Nasya.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of changes will be assessed on the basis of UPDRS
(Unified Parkinson’s disease Rating Scale) (modified) before and after the treatment. |
Assessment will be done at
Day 0, Day 16, Day 31 and after follow-up of 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of changes in following specific signs and symptoms of Kampavata
1 kampa
2 chestasang
3 stambha
4 gati vikriti
5 avanamna
6 vak vikriti
(PD).
|
at the base line day and After completion of trial. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/06/2022 |
| Date of Study Completion (India) |
14/08/2023 |
| 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)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Parkinson’s disease (PD) is a group of progressive neurodegenerative disorders
characterized by tremor, akinesia, bradykinesia, muscular rigidity, abnormalities of posture,
impairment of postural control and balance, abnormalities of gait, dysphonia, dysarthria and
stammer. In Ayurveda the Vata Dosha which is the motivator and controller of other two Dosha
i.e.,Pitta and Kapha, is responsible for almost all types of diseases. All motor and sensory
functions are control by Vata Dosha. According the Ayurveda Major neurological problems
come under Vata Vyadhi, Kampavata is one of them. Kampavata is that condition caused by
Vata in which all the part of the body including the head will have tremors. Ayurveda takes a unique approach to the management of Vata Vyadhi (Kampa vata/PD) with a
special emphasis on eliminating their cause by Panchakarma. Panchakarma procedures like
different types of Snehana, Swedana , Vamana, Virechana, Basti and Nasya Karma are
especially indicated in the treatment of neurological diseases. Besides a special treatment like
Shirobasti, Shirodhara, Nasya and Basti karma are indicated in such diseases. GROUPING:- After the complete examination and investigation, all the 30 patients will be
divided into two groups (15 patients in each group) detail as below-
ï‚· Group A- Tritiya Baladi Yapana Basti along with Shirobasti for 16 days
followed by Kauncha Paka 10 gm twice a
day after meal
for 15 days.
ï‚· Group B- Nasya along with Shirobasti for 16 days followed by Kauncha Paka 10 gm twice a
day after meal
for 15 days. |