| CTRI Number |
CTRI/2024/07/070803 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
16/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [agnikarma ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Agnikarma With Tamra Shalaka In The Management Of Kamala Or Jaundice |
|
Scientific Title of Study
|
A Randomised Clinical Study To Evaluate The Effect Of Agnikarma With Tamra Shalaka In The Management Of Bahupitta Kamala W.S.R. To Hepato-Cellular Jaundice. |
| 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 Anisha Khandelwal |
| Designation |
Post Graduate Scholar |
| Affiliation |
SDM Ayurveda Hospital, Kuthpady, Udupi, Karnataka |
| Address |
Department of Shalya Tantra ,
SDM Ayurveda Hospital,Kuthpady, Udupi Karnataka.
Udupi
KARNATAKA
574118
India |
| Phone |
7795696610 |
| Fax |
|
| Email |
dr.anishak16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajneesh V Giri |
| Designation |
Professor |
| Affiliation |
SDM Ayurveda Hospital, Kuthpady, Udupi ,Karnataka |
| Address |
Department Of Shalya Tantra
Sri Dharmasthala Manjunatheshwara College Of Ayurveda,Kuthpady,Udupi 574118.
Udupi
KARNATAKA
574118
India |
| Phone |
9845407543 |
| Fax |
|
| Email |
drrajneeshgiri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajneesh V Giri |
| Designation |
Professor |
| Affiliation |
SDM Ayurveda Hospital, Kuthpady, Udupi, Karnataka |
| Address |
Department Of Shalya Tantra
Sri Dharmasthala Manjunatheshwara College Of Ayurveda,Kuthpady,Udupi,574118
Udupi
KARNATAKA
574118
India |
| Phone |
9845407543 |
| Fax |
|
| Email |
drrajneeshgiri@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OFAYURVEDA, KUTHPADY,UDUPI,574118. |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital |
| Address |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital,Kuthpady,Udupi, Karnataka |
| 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 Anisha Khandelwal |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital |
Department Of Shalya Tantra, opd number 5,Sri Dharmasthala Manjunatheshwara College Of Ayurveda,Kuthpady,Udupi,574118
Udupi
KARNATAKA |
7795696610
dr.anishak16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital Udupi, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K768||Other specified diseases of liver. Ayurveda Condition: KAMALA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Arogyavardhini vati, Reference: AFI, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: -(2) Medicine Name: Punarnava mandoora, Reference: AFI, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Butter milk), Additional Information: - | | 2 | Intervention Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Basavarajiyam, Procedure details: Valaya Agnikarma with Tamra Shalaka near Manibandha sandhi (Anatomical snuff box) of Right Hand.
)
(1) Medicine Name: Arogyavardhini vati, Reference: AFI, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: tds, Duration: 15 Days(2) Medicine Name: Punarnava mandoora, Reference: AFI, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: tds, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with diagnostic features of Bahupitta Kamala/ Hepato-cellular Jaundice for minimal of 7 days.
|
|
| ExclusionCriteria |
| Details |
1.Patients contraindicated for Agnikarma as per texts.
2.Patients with Total bilirubin level more 10mg/dl.
3.Patients with Alkaline phosphate levels greater than double the normal range (i.e more 300 IU)
4.Pregnancy or lactating women.
5.Bleeding disorders.
6.Uncontrolled Diabetes mellitus (HbA1C more 7%)
7.Cardiac diseases [Ischemic heart disease, Coronary heart disease, Myocardial infarction]
AIDS, TB, Hepatitis B and Hepatitis C.
8.Obstructive Jaundice
9.Tumors of Hepato-biliary system.
10.Any other symptomatic illness which interferes in treatment. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Decreased levels of Total bilirubin,SGOT,SGPT,Alkaline Phosphatase. |
1.15 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.The condition of the patient will be assessed before & after the treatment.
2.Assessment will be made by taking LFT levels on BT, 7th & 15th day of the treatment.
3.Total bilirubin levels & alkaline phosphate levels will be monitored on every 3rd day (i.e. 3rd,7th, 10th ,13th & 15th day) of the treatment. |
15 Days |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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)
|
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
|
|
Brief Summary
|
Agnikarma has the ability to cure chronic diseases that cannot be cured by Bheshaja, Shastra and Kshara Karma.For Kamala rogi, agnikarma with swarna or tamra or rajata shalaka is mentioned. Based on samprapti, Kamala is manifested in two forms, Kostha Shakashrita Kamala (Bahupitta kamala) and Shakashrita Kamala (Alpa pitta kamala). Clinically they are mainly characterized by Haridra Netra, Twak, Nakha, Mootra and differentiated by Shweta varcha and Rakta peeta varcha respectively. Jaundice is a yellowish discoloration of the skin and mucous membranes caused by hyperbilirubinemia. Jaundice becomes visible when the bilirubin level is above 2 to 3 mg/dL. In India it is 2.37-3.25 per 1000 population.Hepatocellular jaundice is an infectious disease affecting liver. Patients usually report darkening of urine before they notice sclera icterus. Patients also complaints of fatigue, anorexia, nausea. Hepatocellular jaundice, which is comparable to Bahupitta kamala based on the symptoms, requires long-term treatment. Therefore, the purpose of this study is to determine whether the effect of medicines can be improved by the addition of Agnikarma and whether the therapeutic days can be reduced, thereby lowering patient treatment costs and hospital stays. A minimum of 30 patients diagnosed with Bahupitta Kamala with their informed consent will be selected and divided into two groups. Group A will be treated by Arogyavardhini vati and Punarnava mandoora. Group B will be treated by Arogyavardhini vati, Punarnava mandoora and Agnikarma. |