| CTRI Number |
CTRI/2025/03/082679 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical experiment to find the effect of bloodletting with daily Purgation therapy for the treatment of liver disease. |
|
Scientific Title of Study
|
A randomized comparative clinical trial study to evaluate the efficacy of ruksha purva and sneha purva siravedhana and nityavirechana in yakrutodara with special reference to non-alcoholic fatty liver disease. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Riva Ajaybhai Joshi |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Panchakarma- OPD No. 105 and IPD, Parul Ayurved Hospital, Parul institute of Ayurved, Parul University, PO - Limda,
Ta- Waghodia, Dis.- Vadodara.
Vadodara
GUJARAT
391760
India |
| Phone |
9427539604 |
| Fax |
|
| Email |
joshiriva99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sangeeta H Toshikhane |
| Designation |
Professor of Deptartment of Panchakarma |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Room No.303, Department of Panchakarma, Parul Institute of Ayurved, Parul University, PO- Limda, Ta- Waghodia, Dis.- Vadodara.
Vadodara
GUJARAT
391760
India |
| Phone |
9964596479 |
| Fax |
|
| Email |
sangeeta.toshikhane26791@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sangeeta H Toshikhane |
| Designation |
Professor of Deptartment of Panchakarma |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Room No.303, Department of Panchakarma, Parul Institute of Ayurved, Parul University, PO- Limda, Ta- Waghodia, Dis.- Vadodara.
Vadodara
GUJARAT
391760
India |
| Phone |
9964596479 |
| Fax |
|
| Email |
sangeeta.toshikhane26791@paruluniversity.ac.in |
|
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Source of Monetary or Material Support
|
| Parul Institute of Ayurved |
|
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Primary Sponsor
|
| Name |
Parul Ayurved Hospital |
| Address |
Parul Ayurved Hospital, Parul institute of Ayurved, Parul University, PO - Limda,
Ta- Waghodia, Dis.- Vadodara. |
| Type of Sponsor |
Research institution and hospital |
|
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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 Riva Joshi |
Parul Ayurved Hospital |
Panchakarma- OPD No. 105 and IPD, Parul Ayurved Hospital, Parul institute of Ayurved, Parul University, PO - Limda,
Ta- Waghodia, Dis.- Vadodara.7980ol.
Vadodara
GUJARAT |
09427539604
joshiriva99@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for human research,Parul institute of Ayurved,Parul university. |
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:K760||Fatty (change of) liver, not elsewhere classified. Ayurveda Condition: YAKRUDDALYUDARAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | sirAvedhaH, सिरावेधः | (Procedure Reference: Su. Sha. 8, Procedure details: Purva karma- Udvartana & Nitya Virechana & Counseling should be done, obtaining written consent, & administering Yavagu before the procedure. Vital signs are checked prior to Siravedhana. Snehapana will be done 2 days prior to the procedures.
Pradhana karma- The patient is positioned comfortably, & the selected vein in the right cubital fossa is punctured after applying a tourniquet & cleaning the area. Blood is collected until it stops naturally & disposed of as per biomedical waste guidelines.
Paschat karma- Removing the tourniquet, cleaning the site, applying a bandage, & advising rest. Rescue medicines are kept ready, & Vatahara Ushna Ahara (like peya & yusha) is provided.)
| | 2 | Comparator Arm | Procedure | - | sirAvedhaH, सिरावेधः | (Procedure Reference: Su. Sha. 8, Procedure details: Purvakarma- Snehpana with Murchhita go ghrita
pradhana karma- Siravedhana karma
paschat karma- bandaging by following aseptic measures)
(1) Medicine Name: Murchhita go ghrita, Reference: Bhaishajyaratnawali 5/1285, Route: Oral, Dosage Form: Ghrita, Dose: 70(ml), Frequency: od, Duration: 2 Days |
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either gender between the age group of 18 to 60.
Patients of grade I, II, and III Non- Alcoholic fatty liver disease.
Both Diagnosed and Newly diagnosed patients.
|
|
| ExclusionCriteria |
| Details |
Patient having history of Ascites, Liver Carcinoma, Liver Cirrhosis, HIV, Anemia.
Patients having history of major Systemic Diseases like IHD, Malignancies.
Pregnant and lactating women.
|
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| To reduce fatty liver Index score by performing Panchakarma procedures like Udvartana, Siravedhana and Nitya virechana in NAFLD. |
13 days and follow up on 20th day |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| To reduce symptoms like Ajirna, Atilalastrava, Aruchi, Chardi, Adhmana, Vibandha |
On 13th day
on 20th day(follow up) |
|
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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" |
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Phase of Trial
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Phase 2/ Phase 3 |
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Date of First Enrollment (India)
|
01/04/2025 |
| 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)
|
Not Applicable |
| 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
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Brief Summary
|
INTRODUCTION:- Non-Alcoholic Fatty Liver Disease (NAFLD) is the accumulation of fat in liver cells, progressing from simple steatosis to severe conditions like cirrhosis. In Ayurveda, it correlates with Yakritodara, involving tridosha imbalance, mandagni, and medodhatu vikriti. Raktamokshana is effective for pittaja and raktaja vikaras, while Udvartana aids fat metabolism. Nitya Virechana helps eliminate Pitta and Ama, improving liver function.NEED FOR STUDY:- NAFLD is a growing health concern, especially in low socio-economic populations, as it can progress to severe liver diseases like NASH and cirrhosis if untreated. Modern treatments focus on managing symptoms but have limitations, including side effects and high costs. This study aims to explore the combined effects of Ruksha Purva (Udvartana) and Sneha Purva (Snehapana) Siravedhana in Yakrutodara, addressing a research gap in holistic liver disease management. Aim:- the efficacy of Ruksha purva and Sneha purva Siravedhana and Nitya Virechana in the management of Yakrutodara w.s.r. to NAFLD. Objectives:-To evaluate the efficacy of Ruksha purva Siravedhana with Nitya Virechana in the management of Yakrutodara. -To evaluate the efficacy of Sneha poorva Siravedhana with Nitya Virechana in the management of Yakrutodara. -To compare the efficacy of Ruksha purva Siravedhana and Sneha purva Siravyadhana with Nitya Virechana in the management of Yakrutodara w.s.r. to NAFLD. n NULL HYPOTHESIS [H0] :-There is no significant difference in the effectiveness of the Ruksha purva and Sneha purva Siravedhana and Nitya Virechana in the management of Yakrutodara w.s.r. to NAFLD. ALTERNATIVE HYPOTHESIS :-(H1) – Ruksha purva Siravedhana and Nitya Virechana is more effective in the management of Yakrutodar as compare to Sneha purva Siravedhana w.s.r. to NAFLD. (H2) – Sneha purva Siravedhana and Nitya Virechana is more effective in the management of Yakrutodar as compare to Ruksha purva Siravedhana w.s.r. to NAFLD. Ø (H3) – Both Sneha Purva and Ruksha Purva Siravedhana, along with Nitya Virechana, have an equal effect in the management of Yakrutodara w.s.r. to NAFLD. INTERVENTIONS:- [ Duration- 13 days (followup on 20th day) Group A:- (Sample – 15) | Udvartana with Yava churna + triphala churna – 5 days in the morning for 30 min Siravedhana – on 7th & 12th day Nitya virechana with Patola katu Rohinyadi kashaya – 7 days 20 ml BD mixed with equal quantity of water Group B :- (Sample – 15)
Nitya virechana with Patola katu Rohinyadi kashaya- 7 days 20 ml BD mixed with equal quantity of water Udvartana with Yava churna +triphala churna – 5 days in the morning for 30 min Sneha pana – 2 days prior to Siravedhana
Siravedhana – on 7th & 12th day
Diagnostic Criteria Ajirna Atilalasrava Chardi Aruchi Adhmana
Vibandha USG : Whole Abdomen (SOS), BT, CT CBC HIV HBsAG HCV
Objective Criteria:- - SGPT, SGOT - Fatty Liver Index INCLUSION CRITERIA:- - Patients of either gender between the age group of 18 to 60 - Patients of grade I, II, and III Non- Alcoholic fatty liver disease. - Both Diagnosed and Newly diagnosed patients
EXCLUSION CRITERIA:-
-
Patient having history
of Ascites, Liver Carcinoma, Liver Cirrhosis, HIV, Anemia.
-
Patients having history of major Systemic Diseases like IHD, Malignancies.
-
Pregnant and lactating
women.
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I
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