| CTRI Number |
CTRI/2024/01/062060 [Registered on: 30/01/2024] Trial Registered Prospectively |
| Last Modified On: |
30/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Siravyadha(blood letting)in vata raktha (gout) |
|
Scientific Title of Study
|
A Randomized clinical study to evaluate the efficacy of sirvyadha with or without jatamayadi lepa in vata - rakta w.s.r to gout |
| 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 Sambu Surendran |
| Designation |
PG scholar MS (AYU) |
| Affiliation |
HASS Ayurveda Mahavidhyalaya Hubballi. |
| Address |
ROOM NO. 17 Department of PG and PhD studies in Shalya tantra Ayurveda Mahavidyalaya and Hospital HeggeriExtension Old Hubballi
Dharwad KARNATAKA 580024 India |
| Phone |
08086926586 |
| Fax |
122 |
| Email |
drsambusurendran@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr SIDDANAGOUDA A PATIL |
| Designation |
Professor Department of PG and PhD studies in Shalya tantra |
| Affiliation |
DepartmHASS Ayurveda Mahavidyalaya and Hospital, HeggeriExtension, Old Hubballi |
| Address |
Department of PG and PhD studies in Shalya tantra Ayurveda Mahavidyalaya and Hospital HeggeriExtension Old Hubballi
Dharwad KARNATAKA 580024 India |
| Phone |
9448565198 |
| Fax |
|
| Email |
drsapatilms@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr SIDDANAGOUDA A PATIL |
| Designation |
Professor Department of PG and PhD studies in Shalya tantra |
| Affiliation |
DepartmHASS Ayurveda Mahavidyalaya and Hospital, HeggeriExtension, Old Hubballi |
| Address |
Department of PG and PhD studies in Shalya tantra Ayurveda Mahavidyalaya and Hospital HeggeriExtension Old Hubballi
Dharwad KARNATAKA 580024 India |
| Phone |
9448565198 |
| Fax |
|
| Email |
drsapatilms@gmail.com |
|
|
Source of Monetary or Material Support
|
| HASS AYURVEDA MAHAVIDHYALAYA AND HOSPITAL HUBBALLI |
|
|
Primary Sponsor
|
| Name |
Dr Sambu Surendran |
| Address |
HASS Ayurveda Mahavidhyalaya,Heggeri colony,Old Hubballi,Hubballi,Karnadaka,580030 |
| 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 Sambu Surendran |
HASS Ayurveda Mahavidhyalaya Hubballi |
Room number 16 , Department of Shalya Thantra, HASS Ayurveda Mahavidhyala , Heggeri colony,Old, Hubballi,Hubballi Dharwad KARNATAKA |
08086926586
drsambusurendran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ayurveda Mahavidhyalaya Hubli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M100||Idiopathic gout. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
a.Subject with hyperuricemia and presenting with lakshanas of Vatarakta.
b.Chronicity less than 5 years,
c.Not associated with complete joint destruction.
d.Uric acid above 7 mg/dl
|
|
| ExclusionCriteria |
| Details |
a. Subject with major illness like hepatitis, AIDS, malignancy and RA factor positive.
b. Subject with uncontrolled diabetes mellitus and hypertension, Koch’s arthritis, Septic arthritis, Chronic renal failure, Severe Systemic multi organ syndromes and uric acid cristal stones.
c. Subjects on opioids, anticoagulant drugs.
d. Classical contraindications for siravyadha procedure.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1)reduction in the range of serum uric acid will be assessed. |
Base line - serum uric acid will be assessed and 1 st sitting of Siravyadha
1 st follow up after 7days and second sitting of siravyadha serum uric acid will be assessed
2 nd follow up 21 days after baseline and 3 rd sitting of siravyadha , serum uric acid will be assessed
3rd followup after 28 days of baseline and 4th sitting of siravyadha , serum uric acid will be assessed
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)reduction in the range of serum uric acid
2) symptomatic changes like pain , burining sensation , swelling & discoloration after inntervention
|
1) monitoring the value of serum uric acid after every sitting of siravyadha that is baseline , after 7days ,14 days , 21 days & 28 days .
2)assessing the grade of symptomatic changes after every sitting of siravyadha that is baseline , after 7days ,14 days , 21 days & 28 days |
|
|
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 4 |
|
Date of First Enrollment (India)
|
10/02/2024 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drsambusurendran@gmail.com].
- For how long will this data be available start date provided 01-12-2023 and end date provided 25-12-2050?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Vatarakta is a metabolic disorder and a grievous medical condition. It is one among Vatavyadi caused due to avarana (occlusion). As the name suggest it is due to the vitiation of Vata Dosha and Rakta Dhatu (blood). Vatarakta is classified in to - Uttana Vatarakta and Gambhira Vatarakta on the basis of dhatu involvement, symptoms of uthana vatarakta are Kandu, Daha, Ruja, Ayama, Toda, Spurana, Kunchana, Raga, Bheda, Gourava and Suptata. Gout is a common type of arthritis; the symptomatology of this has striking similarities with those explained in Vatarakta This is due to excess accumulation of uric acid in the blood stream which forms crystals in the joint that causes intense pain, swelling and stiffness in phalanges, it usually affects the joint of the big toe and is marked by transient painful attacks of acute arthritis initiated by crystallization of urates,eventually it leads to chronic gouty arthritis and the deposition of masses of Monosodium Urate (MSU) crystals in joints and other sites, creating tophi. The essential biochemical requirement for the development of clinical gout is hyperuricemia. The management of Vatarakta aims at Vata Hara and Rakta Prasadaka measures. In this respect the Shodhana chikitsa like Raktamokshana (Siravyadha) is advised as primary treatment by Acharya, Raktamokshana (Siravyadha) is a unique subset of accredited drugless surgical technique in Ayurveda; often ignored, misunderstood in the mainstream practice. It is indicated primarily in generalized vitiation of blood, causing distress. Siravyadha treatment relieves the symptoms early, modifies the underlying pathology and also reduces the duration of treatment. it can bring down the oral medicine burden to the patient which has to be taken for years together. In sahasrayoga, thaila prakarana, kalka dravya of balaguluchyadi taila i.e., Jadamayadhi churna which ingredients are sheeta veerya can reduces raga, shopha, daha and shola caused due to vata rakta. |