| CTRI Number |
CTRI/2024/07/069925 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
03/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Clinical study to evaluate the role of basti karma (enema therapy) and virechan karma (purgation therapy) in hyperuricemia. |
|
Scientific Title of Study
|
Double arm Clinical trial to evaluate the role of basti karma and virechan karma in hyperuricemia. |
| 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 Nitin Jindal |
| Designation |
Associate Professor |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Department of Panchakarma, Ayurvedic and Unani Tibbia College and Hospital, Ajmal Khan Rd, Block 56, Karol Bagh, New Delhi, Delhi 110005
Central
DELHI
110005
India |
| Phone |
9811765501 |
| Fax |
|
| Email |
nitjin2005@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nitin Jindal |
| Designation |
Associate Professor |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Department of Panchakarma, Ayurvedic and Unani Tibbia College and Hospital, Ajmal Khan Rd, Block 56, Karol Bagh, New Delhi, Delhi 110005
DELHI
110005
India |
| Phone |
9811765501 |
| Fax |
|
| Email |
nitjin2005@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ritika Nagpal |
| Designation |
MD Scholar |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Department of Panchakarma, PG room, Ayurvedic and Unani Tibbia College and Hospital, Ajmal Khan Rd, Block 56, Karol Bagh, New Delhi, Delhi 110005
Central
DELHI
110005
India |
| Phone |
7982343762 |
| Fax |
|
| Email |
ritikanagpal99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Panchakarma, Ayurvedic and Unani Tibbia College and Hospital, Ajmal Khan Rd, Block 56, Karol Bagh, New Delhi, Delhi 110005 |
|
|
Primary Sponsor
|
| Name |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Department of Panchakarma, Ayurvedic and Unani Tibbia College and Hospital, Ajmal Khan Rd, Block 56, Karol Bagh, New Delhi, Delhi 110005 |
| Type of Sponsor |
Government 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 Ritika Nagpal |
Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh, New Delhi |
Department Of Panchakarma, Ayurvedic and Unani Tibbia College and Hospital, Ajmal Khan Rd, Block 56, Karol Bagh, New Delhi, Delhi 110005
Central
DELHI |
7982343762
ritikanagpal99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Ayurvedic and Unani Tibbia College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E790||Hyperuricemia without signs of inflammatory arthritis and tophaceous disease. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: Charak samhita chikitsa sthan adhyay 29, Procedure details: Pachana will be done using Patoladi kwath 40ml BD upto niraam lakshana, followed by Snehapana using Kalyanak ghrita starting in & continue in aarohan krama upto samyak snigdha lakshana.
Thereafter, Sarvanga abhyanga (using Pind taila) and Sarvanga swedana will be done for 3 days. Virechana karma will then be performed using Trivritta avleha 30-60grams (as per the koshtha) and triphala kwath (150-200ml)followed by Samsarjana krama.
)
(1) Medicine Name: Patoladi kwath, Reference: Charak samhita chikitsa stha adhyay 1, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 40(ml), Frequency: bd, Duration: 5 Days(2) Medicine Name: Kalyanaka ghrita, Reference: Charak Samhita chikitsa sthan adhyay 9, Route: Oral, Dosage Form: Ghrita, Dose: 30(ml), Frequency: od, Duration: 7 Days(3) Medicine Name: Trivritta avleha, Reference: Ashtang Hridaya kalpasthan adhyay 2, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 40(g), Frequency: od, Duration: 1 Days | | 2 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Charak samhita siddhi sthan adhyay 3, Procedure details: According to the ayurvedic classical texts, The vatanuloman drug(erand tail) will be given to the
patient at the bed time of the day before basti. Anuvasana basti will be administered by
Balaguduchyadi taila & Niruha basti by Yashtahyadi ksheer basti in the form of kaala basti.
Time of administration for Niruha Basti- Empty stomach i.e early in the morning.
Quantity of administration for Niruha basti- 450-500ml.
Time of administration for Anuvasana basti- Immediate after meal.
Quantity of oil for administration for Anuvasana basti-90 ml.
Duration- 15-20 days. )
(1) Medicine Name: Yashtahyadi ksheer basti, Reference: Charak samhita siddhi sthan adhyay 3, Route: Rectal, Dosage Form: Ksheerpaka, Dose: 500(ml), Frequency: od, Duration: 6 Days(2) Medicine Name: Balaguduchyadi taila, Reference: Sahasrayoga Tailaprakarana- 14, Route: Rectal, Dosage Form: Taila, Dose: 90(ml), Frequency: od, Duration: 90 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients attending out patient department with Sr. Uric Acid levels greater than 7.0mg/dl will be
enrolled in the study. |
|
| ExclusionCriteria |
| Details |
Patients who are contraindicated for Basti karma will not be included in Group A and for those who are contraindicated for Virechan karma will not be included in Group B. For both groups: Rectal prolapse, Fever, Pregnant and lactating mothers etc. For Group A: Udar rog, intestinal perforation, intestinal obstruction etc. For Group B: Loss of bowel control, atisara(diarrhea) etc
Known case of Rheumatoid Arthritis, Psoriatic Arthritis
Patients with renal or hepatic impairment (Sr creatinine greater than 1.8mg/dl along with Sr Urea greater than 60 mg/dl, SGOT and SGPT greater than Five times of upper limit Patients having LDL and Triglycerides greater than two times of upper limit
Patients with co-morbid conditions such as Hypertension grade 2 greater than equal to 160/100mm of Hg) or more, Diabetes Mellitus (having HbA1c greater than 7.5% with or without hyperglycemicmedications
Patients who are on anti tubercular or anti retroviral medication
Patients requiring emergency treatment
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The proportion of patients showing improvement in the level of Sr. Uric acid
post Basti karma and Virechan karma.
|
At baseline.
16th day
31st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The proportion of patients showing changes in the inflammatory cytokine IL-6 & CRP post Basti karma & Virechan karma. |
At baseline
31st day |
| Assessment of features of vatarakta in patients of Hyperuricemia. |
At baseline
16th day
31st day |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/07/2024 |
| 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 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
|
A serum urate level over the top limit of the normal reference range is referred to as hyperuricemia, and it is thought to be a significant biochemical detection marker for the diagnosis of gout. Recent research indicates that gout and hyperuricemia are on the rise globally, and that this is significantly increasing the socioeconomic burden associated with them, including medical costs. In contemporary medicine, the standard of care consists of NSAIDs, colchicine, and glucosecocorticoids, which are commonly associated with negative side effects and fail to alter the course of the condition or treat it.According to acharya charak, The greatest treatment for the vatarakta is basti (enema). Basti (enema therapy) is the greatest option when this condition involves the leg, which is symptomatic of major vata vitiation. Every kind of vatarakta emphasizes the administration of ksheera vasti, the major ingredient being milk. Also, Snehayukta mridu virechak dravya should be utilized regularly after realizing that purisha obstructs the marga of vata.The goal of the current study is to assess how well Virechan and Basti work to lower uric acid levels in people with hyperuricemia. According to reports, gout patients had considerably higher serum levels of pro-inflammatory cytokines such TNF-α and interleukin-6 (IL-6) than healthy controls. Additionally, this study is done to assess the relation between Sr. uric acid and IL-6 in patients of hyperuricemia and the effect of basti and virechan karma on the disease specific inflammatory cytokine IL-6. |