| CTRI Number |
CTRI/2024/10/075322 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
07/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to know the benefit of Prabhakar vati and Sarpagandha vati in shonita dusti with reference to essential hypertension |
|
Scientific Title of Study
|
A comparative clinical to evaluate the efficacy of prabhakara vati with sarpagandha vati in shonita dusti with special reference to essential hypertension |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jyoti Ashok Belavi |
| Designation |
PG Scholar |
| Affiliation |
Shri Shivayoogeeshwar Rural Ayurvedic College Hospital Inchal |
| Address |
Shri Shivayoogeeshwar Rural Ayurvedic College and Hospital Inchal -591102 kayachikitsa department
Tq-Savadatti Dist-Belagavi
Shri Shivayoogeeshwar Rural Ayurvedic College and Hospital Inchal
Belgaum
KARNATAKA
591102
India |
| Phone |
8073224705 |
| Fax |
|
| Email |
belavijyoti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jyoti Ashok Belavi |
| Designation |
PG Scholar |
| Affiliation |
Shri Shivayoogeeshwar Rural Ayurvedic College Hospital Inchal |
| Address |
Shri Shivayoogeeshwar Rural Ayurvedic College and Hospital Inchal Kaya chikitsa department
Tq-Savadatti Dist-Belagavi
Shri Shivayoogeeshwar Rural Ayurvedic College and Hospital Inchal
Belgaum
KARNATAKA
591102
India |
| Phone |
8073224705 |
| Fax |
|
| Email |
belavijyoti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jyoti Ashok Belavi |
| Designation |
PG Scholar |
| Affiliation |
Shri Shivayoogeeshwar Rural Ayurvedic College Hospital Inchal |
| Address |
Shri Shivayoogeeshwar Rural Ayurvedic College and Hospital Inchal Kaya chikitsa department
Tq-Savadatti Dist-Belagavi
Shri Shivayoogeeshwar Rural Ayurvedic College and Hospital Inchal -591102 kayachikitsa department
Tq-Savadatti Dist-Belagavi
Belgaum
KARNATAKA
591102
India |
| Phone |
8073224705 |
| Fax |
|
| Email |
belavijyoti@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Shivayogeeshwar Rural Ayurvedic College and Hospital Inchal |
|
|
Primary Sponsor
|
| Name |
Jyoti Ashok Belavi |
| Address |
SSRAMC Inchal |
| Type of Sponsor |
Private medical college |
|
|
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 Jyoti |
Dr. Jyoti |
Shri Shivayoogeeshwar Rural Ayurvedic College and Hospital Inchal -591102 kayachikitsa department
Tq-Savadatti Dist-Belagavi
Belgaum
KARNATAKA |
8073224705
belavijyoti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Clearance Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I00-I99||Diseases of the circulatory system. Ayurveda Condition: RADITA/RUDITA-DASHTAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Prabhakar vati, Reference: Govindadas. Bhaisajya Ratnavali. Shri Lalchandra vaidya editor. Varanasi- Chaukhambha orientalia.sloka .Pp820, p438., Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: ushna jala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: sarpanaganda vati, Reference: Yadavji trikamji acharya.Siddhayoga sangraha.11 edition.Shri baidhyanartha Ayurveda bhavan limited Naini.2003.chapter-19. Pp164,p101, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Usher jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with samanya lakshana of Shonita dusti. |
|
| ExclusionCriteria |
| Details |
Patients with history of cerebrovascular accident, chronic kidney disease. diabetic mellitus
other systemic,Metabolic disorders.
Patients having secondary hypertension.
Patients with history of Disorders related with haemopoietic system like Leukemia
Hemophilia
Unconscious, Coma patient, and Patients who are suffering with Gastro-intestinal
bleeding disorders. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Headache reduced |
After 14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improved in generalised weakness and daily activities |
After 21 days of treatment |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/10/2024 |
| 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="0"
Months="0"
Days="21" |
|
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
|
The samanya chikitsa of Shonita dusti is Raktapittahara kriya, Virechana, Upavasaa and Rakta sravana . In that Raktapittahara kriya plays vital role in planning the treatment,which mainly aimed as Vyadhipratyanika and Samprapti vighatana Chikitsa. On classical literature analysis the main siddhanta of chikitsa is Samprapti vighatana of the disease. Prabhakar vati is one such drug which is mentioned in Hrudrogadhikar of Bhaishajya Ratnavali. Its constituents helps to do Samprapti vighatana of Shonita dusti and also helps to prevent further complications caused by Essential hypertension, as it contains swarnamakshika bhasma, Loha bhasma, Abhraka bhasma, Vamshalochana, Shilajatu and Arjuna kwath as bhavana dravya . It is having Madhura, Tikta rasa, Sheeta veerya and overall karmukata is Pitta Shamana with Tridosha hara properties. Thus does the Shamana of Vyadhis caused by Shonita dusti . Hence Prabhakra vati is choosen for the current study.Sarpagandha vati is explained under Brama-Anidra-Unmad adhikar of Siddhayoga sangraha and it contains Sarpagandha, Jatamansi, Parasika Yavani, Pippalimoola, Bhanga.Sarpagandha vati is having predominantly having Tikta rasa and act as Raktashodhaka. It is nidrajanak and a nutrient for brain, which can be used to relieve anxiety, stress and mental fatigue |