| CTRI Number |
CTRI/2024/07/070428 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
02/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to evaluate the efficacy of Maharasnadi Kashaya and Kapikacchu Choorna with Shuddha Bala Taila Matra Bati in the management of Kampavata (Parkinsons Disease). |
|
Scientific Title of Study
|
A randomized open labelled comparative clinical study to evaluate the efficacy of oral administration of Maharasnadi Kashaya and Kapikacchu Choorna with Shuddha Bala Taila Matra Basti in the management of Kampavata with special reference to Parkinsons Disease. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prekshna Gabriella Paul |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and research |
| Address |
OPD No.5 Dept of PG Studies in Kayachikitsa Sri Sri College of Ayurvedic Science and Research Hospital 21st Km Kanakapura Rd Udayapura PO OB Chudahalli
Bengaluru
Karnataka
560082
India
Bangalore
KARNATAKA
560082
India |
| Phone |
9632468003 |
| Fax |
|
| Email |
prekshnapaul@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gayathri R |
| Designation |
Associate professor |
| Affiliation |
Sri Sri College of Ayurvedic Science and research |
| Address |
OPD No.5 Dept of PG Studies in Kayachikitsa Sri Sri College of Ayurvedic Science and Research Hospital 21st Km Kanakapura Rd Udayapura PO OB Chudahalli
Bengaluru
Karnataka
560082
India
Bangalore
KARNATAKA
560082
India |
| Phone |
9632468003 |
| Fax |
|
| Email |
drgayathrig3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prekshna Gabriella Paul |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and research |
| Address |
OPD No.5 Dept of PG Studies in Kayachikitsa Sri Sri College of Ayurvedic Science and Research Hospital 21st Km Kanakapura Rd Udayapura PO OB Chudahalli
Bengaluru
Karnataka
560082
India
Bangalore
KARNATAKA
560082
India |
| Phone |
9632468003 |
| Fax |
|
| Email |
prekshnapaul@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD No.5 Dept of PG Studies in Kayachikitsa Sri Sri College of Ayurvedic Science and Research Hospital 21st Km Kanakapura Rd Udayapura PO OB Chudahalli
Bengaluru
Karnataka
560082
India |
|
|
Primary Sponsor
|
| Name |
Dr Prekshna Gabriella Paul |
| Address |
OPD No5 Dept of PG Studies in Kayachikitsa Sri Sri College of Ayurvedic Science and Research Hospital 21st Km Kanakapura Rd Udayapura PO OB Chudahalli
Bengaluru
Karnataka
560082
India |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prekshna Gabriella Paul |
Sri Sri College of Ayurvedic Science and Research Hospital Bengaluru |
OPD No.5 Dept of Kayachikitsa Sri Srin College of Ayurvedic Science and Research Hospital 21st KM Kanakapura Rd Udayapura PO OB Chudahalli
Bangalore
KARNATAKA |
9632468003
prekshnapaul@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SRI INSTITUTIONAL ETHICAL COMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G20||Parkinsons disease. Ayurveda Condition: KAMPAH/VEPATHUH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Sushruta Chikitsa 37/-, Procedure details: Poorva karma: Abhyanga- Stanika abhyanga to abdomen, buttocks & thighs with Shuddha bala taila for 20 minutes. Swedana- Nadi sweda with ushna jala for 10 minutes. Pradhana karma: Matra basti with Shuddha Bala Taila (72ml) will be given after food. Paschat karma: Lift both legs, patting the buttocks, & massage the abdomen in an anticlockwise motion)
(1) Medicine Name: Shuddha bala taila, Reference: Sahasrayogam-Taila prakarna, Route: Rectal, Dosage Form: Taila, Dose: 72(ml), Frequency: od, Duration: 9 Days(2) Medicine Name: Maharasnadi Kashaya, Reference: Sharangadhara Samhita madhyama khanda 2/89-95, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 50(ml), Frequency: bd, Duration: 30 Days | | 2 | Comparator Arm | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Sushruta Chikitsa 37/-, Procedure details: Poorva karma: Abhyanga- Stanika abhyanga to abdomen, buttocks & thighs with Shuddha bala taila for 20 minutes. Swedana- Nadi sweda with ushna jala for 10 minutes. Pradhana karma: Matra basti with Shuddha Bala Taila (72ml) will be given after food. Paschat karma: Lift both legs, patting the buttocks, & massage the abdomen in an anticlockwise motion)
(1) Medicine Name: Shuddha bala taila, Reference: Sahasrayogam-Taila prakarna, Route: Oral, Dosage Form: Taila, Dose: 72(ml), Frequency: od, Duration: 9 Days(2) Medicine Name: Kapikacchu Choorna, Reference: Ashtanga hrudhaya sutrastana 27/24-34, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Duration: 30 Days |
|
|
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Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects presenting with the lakshanas of Kampavata like karapaadatale kampa(tremors), deha bhramana (whirling sensation), nidrabhanga(sleeplessness) and kshinamati (dementia).
2) Subjects presenting the clinical features of PD like tremors, rigidity, bradykinesia.
3) Subjects who have been freshly diagnosed with Idiopathic PD or less than 5 year history and those who are not on any medications for Parkinson’s disease.
4) Subjects irrespective of gender in between the age group 40 to 65 years.
5) Subjects who are indicated and fit for Matra basti.
6) Subjects willing to participate with written informed consent, which is conveyed in the
language, which the subject can understand. |
|
| ExclusionCriteria |
| Details |
1) Subjects with other varieties of Tremors like essential tremors, senile tremors.
2) Subjects who are on any medications for Parkinson’s disease.
3) Subjects diagnosed with uncontrolled systemic diseases like HTN and DM.
4) Subjects with history of Major head injury. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant decrease in symptoms of Parkinson’s Disease assessed based on MDS-UPDRS Scale. |
Before intervention- 0th day
After intervention- 30th day
Follow up- 45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
RESEARCH QUESTION Whether oral administration of Maharasnadi kashaya along with Shuddha Bala taila matra basti and Kapikachu choorna along with Shuddha Bala Taila Matra Basti is effective in the management of Kampavata with special reference to Parkinson’s Disease?
HYPOTHESIS Null Hypothesis (H 0 ) = There is no significant difference between the two groups in the clinical efficacy of Maharasnadi kashaya orally along with Shuddha Bala taila matra basti and Kapikachu choorna orally along with Shuddha Bala taila matra basti in the management of Kampavata with special reference to Parkinson’s Disease.
Alternative Hypothesis (H 1 ) = The clinical efficacy of Maharasnadi kashaya orally along with Shuddha Bala taila matra basti is better than Kapikachu choorna orally along with Shuddha Bala taila matra basti in Kampavata with special reference to Parkinson’s Disease.
Alternative Hypothesis (H 2 ) : The clinical efficacy of Kapikachu choorna orally along with Shuddha Bala Taila Matra Basti is better than Maharasnadi kashaya orally along with Shuddha Bala taila matra basti in Kampavata with special reference to Parkinson’s Disease.
6.4 AIM AND OBJECTIVES OF THE STUDY: AIM: To clinically evaluate and compare the efficacy of Maharasnadi kashaya with that of Kapikachu choorna along with Shuddha Bala taila matra basti in the management of Kampavata with special reference to Parkinson’s Disease.
OBJECTIVES OF THE STUDY: Primary objective: ◠To clinically evaluate the efficacy of Maharasnadi kashaya with Shuddha Bala taila matra basti in the management of Kampavata with Movement Disorder Society- unified Parkinson’s Disease Rating Scale (MDS-UPDRS) in the clinical setting of the institution. ◠To clinically evaluate the efficacy of Kapikachu choorna with Shuddha Bala taila matra basti in the management of Kampavata with MDS-UPDRS scale in the clinical setting of the institution. ◠To clinically compare and evaluate the efficacy of Maharasnadi kashaya and Shuddha Bala taila matra basti with Kapikachu choorna and Shuddha Bala taila matra basti in management of Kampavata with MDS-UPDRS scale in the clinical setting of the institution.
Secondary objective: ◠To undertake the detailed literary review of Kampavata with special reference to Parkinson’s Disease. |