CTRI Number |
CTRI/2022/10/046120 [Registered on: 03/10/2022] Trial Registered Prospectively |
Last Modified On: |
30/09/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda Process of Care Changes |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
A Comparative Study of the Efficacy of Vasaadi Kwath (decoction of Vasa and other herbs) and Raktamokshan (bloodletting) by Sira Vedhan (puncturing the vein) in the Management of Vatarakta W.S.R. to Gout (joints disorder of disturbed metabolism) |
Scientific Title of Study
|
A Comparative Study of the Efficacy of Vasaadi Kwath and Raktamokshan by Sira Vedhan in the Management of Vatarakta W.S.R. 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 Ankit Saini |
Designation |
PG Scholar |
Affiliation |
Shri krishna Govt. Ayurvedic College& Hospital |
Address |
Room no. - 102 PG Department of Shalya tantra, Shri Krishna Govt Ayurvedic College and Hospital sec -8 , Umri road
Kurukshetra
HARYANA
136118
India
Kurukshetra HARYANA 136118 India |
Phone |
8168296964 |
Fax |
|
Email |
ankitsaini094@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Rajender Singh |
Designation |
Associate Professor |
Affiliation |
Shri krishna govt ayurvedic college and hospital |
Address |
Room no. - 102 PG Department of Shalya tantra, Shri Krishna Govt Ayurvedic College and Hospital sec -8 , Umri road
Kurukshetra
HARYANA
136118
India
Kurukshetra HARYANA 136118 India |
Phone |
9416662761 |
Fax |
|
Email |
drrajendersingh1346@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Ankit Saini |
Designation |
PG Scholar |
Affiliation |
Shri krishna Govt. Ayurvedic College& Hospital |
Address |
Room no. - 102 PG Department of Shalya tantra, Shri Krishna Govt Ayurvedic College and Hospital sec -8 , Umri road
Kurukshetra
HARYANA
136118
India
Kurukshetra HARYANA 136118 India |
Phone |
8168296964 |
Fax |
|
Email |
ankitsaini094@gmail.com |
|
Source of Monetary or Material Support
|
Shri Krishna AYUSH University
|
|
Primary Sponsor
|
Name |
Shri Krishna AYUSH University Kurukshetra |
Address |
Umri road, Sector 8, Kurukshetra - 136118 |
Type of Sponsor |
Research institution and hospital |
|
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 Ankit Saini |
Shri Krishna Govt. Ayurvedic College & Hospital |
Room no. 103, pg department of shalya tantra, shri krishna govt. Ayurvedic college & hospital Umari Road Sector 8
Rewari
HARYANA Kurukshetra HARYANA |
8168296964
ankitsaini094@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee of University |
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 | Drug | Classical | | (1) Medicine Name: vasaadi kwath, Reference: bhavprakash, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - | 2 | Comparator Arm | Procedure | - | sirAvedhaH, सिरावेधः | (Procedure Reference: , Procedure details: Raktamokshan by Siravedhan will be done on 1st, 7th ,14th and 21. Follow-up will be done on every 7th day)
| 3 | Comparator Arm | Procedure | - | sirAvedhaH, सिरावेधः | (Procedure Reference: sushruta samhita, Procedure details: Raktamokshan by Siravedhan will be done on 1st, 7th ,14th and 21. Follow-up will be done on every 7th day) (1) Medicine Name: vasaadi kwath, Reference: bhavprakash, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 40(ml), Frequency: bd, Duration: 21 Days |
|
|
Inclusion Criteria
|
Age From |
25.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1. Patients with clinical features of Vatarakta
2. Patients of either sex
3. Patients having age group of 25-65 years.
4. Willingness of patients for study
5. Patients having serum uric acid level >7.0 mg/dl in male and >6.0 mg/dl in females. |
|
ExclusionCriteria |
Details |
1. Age below 25 years & above 65 years
2. Uncontrolled Diabetes mellitus, hypertension, COPD
3. Known case of any type of Tuberculosis &HIV Patients
4. HBsAg AND HCV Positive patients
5. Anemia (hemoglobin <7.00mg/dl), jaundice
6. Pregnancy
7. Leukemia
8. Patients unwilling to participate in the trial
9. Paralysis
10. Known case of any blood disorder like sickle cell anemia, Thrombocytopenia etc. |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Alternation |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
1. Sandhishool
2. Sandhishoth
3. SparshaAshtava
4. Raga
5. TwakVaivarnya
6. Stabdhta
7. Vidaha
8. Levels of uric acid
|
At 1st, 7th, 14th & 21st day |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. Sandhishool
2. Sandhishoth
3. SparshaAshtava
4. Raga
5. TwakVaivarnya
6. Stabdhta
7. Vidaha
8. Levels of uric acid |
At 1st, 7th, 14th & 21st day |
|
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 2/ Phase 3 |
Date of First Enrollment (India)
|
03/10/2022 |
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 Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Ayurveda the “Science of
life†or longevity is the holistic alternative science since era. The whole
philosophy of Ayurveda is based on achieving, maintaining and prompting
positive health. The equilibrium of various structural and functional units of
body namely doshas, dhatu, mala, agni, indriya, atma and mann results in a
healthy body. Vatarakta is a disease which is encountered in the
population leading to sedentary life style.
The description of Vatarakta
is found in Brihattrayi and other classical books also. Acharya Charak
includes Vatarakta in raktajroga in rakta dustijanyavikara[1]
and also give its whole description as a separate diseases entity in
chikitsasthan. In Shushrut Samhita it is described in vatavyadhi adhyaya.
The factor said in the classics which are responsible for Vatarakta is
virudhahara and mithya vihara.[2] These leads to the vitiation of
vayu and rakta aggravated, Vata paves for vitiation of rakta in turn leading to
further aggravation of Vata thus evolves condition Vatarakta. In Charak Samhita
synonyms of Vatarakta is khudd, vatablas, adhyavata.[3] Because
it occurs mostly in rich person due to an inappropriate relationship with their
environment.
In modern medical sciences
the characteristics of Vatarakta resemble with those of Gout
therefore it can be better correlated to Gouty arthritis.
GOUT is an abnormality of
purine metabolism that causes hyperuricemia and deposition of monosodium urate
crystal in Joints-acute Gouty arthritis, In soft tissues-causing tophi
and tenosynovitis, In renal tubules-causing urate stones and urate nephropathy.[4]
While talking about
treatment of Vatarakta Acharya Sushrut advised to perform Raktamokshan
repeatedly [5]
jDrÃcys·I;soacgq’k’p ’k®f.kreolsp;sr~â€â€â€â€â€â€â€â€â€â€â€â€â€â€â€â€â€â€â€â€â€â€â€â€â€â€â€â€â€â€AA
¼lqâ€laâ€fpâ€5@9½
Acharya Sushrut explained the
shastiupkarma and described raktavisravana is very useful in vedanaupshamna and
to relieve achirottitashopha.[6]
Acharya Sushrut consider rakta as a fourth
dosha.[7] Expulsion or removal of vitiated rakta as well as other
vitiated doshas from the body is called Raktamokshan. Amongest various
methods of Raktamoshana like shring, jalauka, alabu and Siravedhan.
Among these Siravedhan is more effective and quicker in action. Siravedhan
has been one of the most commonly used therapeutic procedure to remove the
vitiated blood with the help of sharp instruments and is specially used to
treat sarvangagata raktadustijanya vikara. It relieves pain and redness
immediately and considered as “Ardhchikitsa†in Shalya tantra.[8]
Acharya Bhavparkash
advised to use Vasaadi kwath to alleviate Vatarakta completely.[9]
oklkxqMqphprqj³~xqykukesj.MrSysuficsrd"kk;eA
Øes.klok±xeI;’ks"kat;snl`XokrÃ’oafodkjeAA
¼ÒkñÃñe/;e [k.M23@6½
The decoction prepared
with Vasa, Guduchi, and Amaltas mixed with Erandtaila should be given to
alleviate generalized Vatarakta.
In this research the
authors are proposed to analyze the efficacy of Vasaadi kwath and Raktamokshan
by Siravedhan for treatment of Vatarakta.
NEED FOR THE STUDY
Due
to the remittent and relapsing nature of Vatarakta (Gout), there
is no permanent cure for the diseases, which is a challenge in present era.
Moreover, it is a potential signal for unrecognized co-morbidities like
metabolic syndrome, Diabetes mellitus, coronary artery diseases and
hypertension.
Although
several drug regimens have been advised for its management in modern science
like NSAIDS, Colchicine, Corticosteroids and Hypouricemic drugs, there use is
associated with adverse effects and certain limitations.
Therefore,
it is essential to find out some alternative therapeutics based on herbs Vasaadi
kwath and Para-surgical procedure i.e Siravedhan in the management of Vatrarakta
(Gout). |