| CTRI Number |
CTRI/2024/08/071793 [Registered on: 01/08/2024] Trial Registered Prospectively |
| Last Modified On: |
17/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Laghumanjisthadi Ghana and Raktamokshan in Gout. |
|
Scientific Title of Study
|
Randomized controlled clinical trial to evaluate the efficacy of Laghumanjisthadi Ghana and Raktamokshan in Vatarakta with special refence to Gout. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pranoti Tukaram Khandekar |
| Designation |
PG Scholar |
| Affiliation |
Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya, Satara |
| Address |
PG department of Kaychikitsa
,Dr M N Aagashe Aryangla Hospital,Shukrawar peth ,Satara Pin 415002
Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya ,Satara Gendamal ,ITI road , Shahupuri ,Satara PIN 415002
Satara
MAHARASHTRA
415002
India |
| Phone |
7397967839 |
| Fax |
|
| Email |
dr.pranoti97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sameer Prahlad Shinde |
| Designation |
Associate Professor |
| Affiliation |
Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya, Satara |
| Address |
PG Department of Kaychikitsa ,Cabin No 2
Dr M N Aagashe Aryangla hospital,shukrawar peth ,Satara PIN 415002
Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya,Satara
Gendamal, ITI road ,Shahupuri , Satara PIN 415002
Satara
MAHARASHTRA
415002
India |
| Phone |
7507043414 |
| Fax |
|
| Email |
sameershubha85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pranoti tukaram Khandekar |
| Designation |
PG Scholar |
| Affiliation |
Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya, Satara |
| Address |
PG Department of Kaychikitsa
Dr M N Aagashe Aryangla Hospital , Shukrawar peth , satara
PIN 415002
Seth Chandanmal Mutha Aryangla Vaidyaka Mahavidyalaya , Satara
Gendamal , ITI road , Shahupri , satara
PIN 415002
Satara
MAHARASHTRA
415002
India |
| Phone |
7397967839 |
| Fax |
|
| Email |
dr.pranoti97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalay Satara PIN 415002 , Maharashtra , India |
|
|
Primary Sponsor
|
| Name |
Dr Pranoti Tukaram Khandekar |
| Address |
Seth Chandanmal Mutha Aryangla vaidyak Mahavidyalay Satara
Gendamal ,ITI road , shahupuri ,satara PIN 415002 |
| 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 Pranoti Tukaram Khandekar |
Seth Chandanmal Mutha Aryangla Vaidyak Mahavidyalay ,Satara |
Room No 4 ,OPD block,Department of Kaychikitsa Dr M N Aagashe Aryangla Hospital ,hospital ,Satara
Satara
MAHARASHTRA |
7397967839
dr.pranoti97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SCM Aryangla Vaidyak Mahavidyalay Satara |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | raktamokShaNam/ SoNitasrAvaH/ asravisrutiH/ SastravisrAvaNam, रकà¥à¤¤à¤®à¥‹à¤•à¥à¤·à¤£à¤®à¥/ शोणितसà¥à¤°à¤¾à¤µà¤ƒ/ असà¥à¤°à¤µà¤¿à¤¸à¥à¤°à¥à¤¤à¤¿à¤ƒ/शसà¥à¤¤à¥à¤°à | (Procedure Reference: Sushrut Samhita Siravyadh , Procedure details: (Procedure Reference: sushrut samhita siravyadh, Procedure details: Procedure details: Siravyadh, Procedure details: Pre procedure 1 Site of Raktamokshan will be selected according to most adjacent joint. 2 Site will be prepared for Raktamokshan Main procedure 1 Scalp vein no 20 will be used for siravedha Maintaining all aseptic precaution will be carried . 2 Additional sitting of Raktamokshan will be done according to severity of symptoms if neccesory. Post procedure 1 After Raktamokshan needle will be withdrawn properly. 2 Bandaging will be done at site of Raktamokshan.) minimum one sitting will be done. more setting will be done as per requirement )
)
(1) Medicine Name: Laghumanjisthadi Ghana, Reference: Sharangdhar Samhita Madhyam Khand Kwath Kalpana, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 21 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Allopurinol | Allopurinol belongs to Xanthine inhibitor group. It is used in standard practice of gout. It helps to achieve hyourecemic effect.Tablet allopurinol or zyloric 100 mg orally once after meal for 21 days. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having clinical signs and symptoms of vatrakta with special reference to gout like Sandhi toda(jiont pricking pain),Sandhi daha(burning sensation),Sparshasahatva(Tenderness),Sandhi shotha (swelling),Raga (redness or discolouration of joint)described in aaaaaaaaayurvedic classics without any bar of caste ,sex,religion .
2 Patient having serum uric acid level above 6 |
|
| ExclusionCriteria |
| Details |
1 Patients having chronicity of vatrakta more than 5 years
2 Patients on Anti platelet aggregation drugs
3 Patients on anti coagulant drugs
4 Patients having bleeding disorders
5 Patients contraindicated for for Raktamokshana
6 Pregnant and Lactating mothers
7 Patients with illness like HIV, Malignancy,Cardiac disease ,Major Liver Disorders ,Uncontrolled Hypertension , End stage Renal disease
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Evaluate the efficacy Hypourecemic effect of Laghumanjisthadi Ghana and Raktamokshan in the management of Vatarakta. |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To evaluate the Hypourecemic effect of Laghumanjisthadi Ghana & Raktamokshan in Vatarakta.
2.To study adverse effect of Laghumanjisthadi Ghana if any
3 To study adverse effect of Raktamokshan if any
4.To study etiopathology of Vatarakta. |
21 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
17/08/2024 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
Vidyapharma publication Vol 2 nd Issue 3rd Oct 2024 |
|
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 - Researchers who provide a methodologically sound proposal.
- 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 [dr.pranoti97@gmail.com].
- For how long will this data be available start date provided 10-07-2024 and end date provided 12-12-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
This is clinical trial Titled as ’ Randomized controlled clinical trial to evaluate the efficacy of Laghumanjisthadi ghana and Raktamokshan in Vatrakta with special reference to Gout.’ As it is controlled active trial there will be two groups included in the study .one with trial drug i,e Laghumanjisthadi Ghana and Raktamokshan another with standard drug i.e allopurinol .Aim of study is search for ayurvedic management of vatrakta i.e gout which is more economic , reliable ,effective and with less side effects. this is comparative study between ayurveda management and standard drug practice of gout. Total sample size is 60 divided into these two group which will be 30 each group .After screening of patients in OPD and IPD level . Patients with cardinal sign and symptoms of vatrakta as per ayurvedic classical texts as well as patients with serum uric acid level above 6 will be selected for trial. Written informed consent will be taken . Laghumanjisthadi Ghana vati will be administered orally in 500 mg BD dose for 21 days along with Raktamokshan .It will be done by siravyadh method using scalp veinset .Additional sittings of Raktamokshan will be done as per neccesity. Tab Allopurinol will be given orally 100 mg OD for 21 days for Non ayurveda Arm .Before and After observation will be recorded in the Case Performa Paper .Follow up will be taken on 11 th and 21 st Day of trial .Patient can be withdrawn if any adverse effect seen or patient is no longer wanted to participate in trial.
Null Hypothesis Laghumanjisthadi Ghana (500mg orally) twice a day for 21 days and Raktamokshan once is not significantly effective in Vatrakta with special reference to gout.
Alternate Hypothesis Laghumanjisthadi Ghana (500 mg orally ) twice a day for 21 days and Raktamokshan once is significantly effective in Vatrakta with special reference to gout.
. |