| CTRI Number |
CTRI/2023/09/057661 [Registered on: 15/09/2023] Trial Registered Prospectively |
| Last Modified On: |
07/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An Ayurvedic Managenment of Uttana Vatarakata Vis-A-Vis Varicose Veins with Seka, Nitya Virechana and Kokilakshadi Kashaya |
|
Scientific Title of Study
|
Evaluation of combined effect of Seka, Nitya Virechana and Kokilakshadi Kashaya in the management of Uttana Vatarakta
vis-à -vis Varicose Veins – An Open Label Single Arm Clinical Study.
|
| 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 Dhanashree S |
| Designation |
PG Scholar |
| Affiliation |
JSS Ayurevda Medical College and Hospital |
| Address |
Department of PG Studies in Panchakarma JSS Ayurevda Medical College and Hospital Lalithadripura road Alanahalli Mysuru- 570028
Mysore KARNATAKA 570028 India |
| Phone |
9535342997 |
| Fax |
|
| Email |
sdhanashree11@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Jyoti |
| Designation |
Reader |
| Affiliation |
JSS Ayurevda Medical College and Hospital |
| Address |
Department of PG Studies in Panchakarma JSS Ayurevda Medical College and Hospital Lalithadripura road Alanahalli Mysuru- 570028
Mysore KARNATAKA 570028 India |
| Phone |
9743517652 |
| Fax |
|
| Email |
jyotivhullale@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Jyoti |
| Designation |
Reader |
| Affiliation |
JSS Ayurevda Medical College and Hospital |
| Address |
Department of PG Studies in Panchakarma JSS Ayurevda Medical College and Hospital Lalithadripura road Alanahalli Mysuru- 570028
KARNATAKA 570028 India |
| Phone |
9743517652 |
| Fax |
|
| Email |
jyotivhullale@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS Ayurevda Medical College and Hospital Lalithadripura road Alanahalli Mysuru |
|
|
Primary Sponsor
|
| Name |
Dr Dhanashree S |
| Address |
JSS Ayurevda Medical College and Hospital Lalithadripura road Alanahalli Mysuru |
| 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 Dhanashree S |
JSS Ayurveda Medical College and Hospital |
Room NO.6,Department of PG Studies in Panchakarma JSS Ayurevda Medical College and Hospital Lalithadripura road Alanahalli Mysuru- 570028Department of PG Studies in Panchakarma JSS Ayurevda Medical College and Hospital Lalithadripura road Alanahalli Mysuru- 570028 Mysore KARNATAKA |
9535342997
sdhanashree11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS Ayurveda Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I831||Varicose veins of lower extremities with inflammation. Ayurveda Condition: UTTANA-VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: Samhitha, Procedure details: Nitya virechana for 7 days(1st - 7th day) with Nimbamritadi Eranda Taila - 20-40ml according to the koshta, in empty stomach, around 8-9am. All the procedures will be done according to the standardised operative procedure protocol. )
| | 2 | Intervention Arm | Procedure | - | sekaH, सेकः | (Procedure Reference: Samhitha, Procedure details: Ekanga Dashamula Ksheera Kashaya Seka : for 7 days(1st-7th day)
Purva Karma : Application of Sahacharadi Taila to lower limbs.
Pradhana Karma : Ekanga Dashamula Ksheera Kashaya Seka to lower limbs in empty stomach, for 20min around 7-8am)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who fulfill diagnostic criteria.
Subjects of age group 20- 65 years, irrespective of gender.
Subjects who are fit for Nitya Virechana and Kashaya Seka.
|
|
| ExclusionCriteria |
| Details |
Subjects having Varicose Veins associated with Venous Ulcer, Deep Vein Thrombosis or Cellulitis.
Subjects with other systemic diseases that would interfere with the study like uncontrolled Diabetes Mellitus, uncontrolled Hypertension, etc.,
Pregnant women and lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Combined effect of Seka Nitya Virechana with internal administration of Kokilakshadi Kashaya in reduction of signs and symptoms of Uttana Vatarakta vis-a-vis Varicose Veins |
0thday- before treatment
8thday- after seka nityavirechana
28thday- after treatment
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Combined effect of Seka Nitya Virechana with internal administration of Kokilakshadi Kashaya in reduction of signs & symptoms of Uttana Vatarakta vis-a-vis Varicose Veins |
28 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 |
|
Date of First Enrollment (India)
|
21/09/2023 |
| 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="5" Days="30" |
|
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
|
Vatarakta is the condition caused by Dushti of Vata and Rakta
,where Prakupita Rakta does Dushana and Margavarana of Vata and
Dushita Vata further does Dushana of Rakta. Vatarakta is of 2
types-Uttana and Gambhira. Uttana Vatarakta Lakshanas
are Kandu, Daha, Ruk, Ayama etc.
Uttana Vatarakta can be co-related to Varicose Veins due to
similarity in its symptoms.
Varicose veins are dilated
tortuous, superficial veins that results from defective structure and functions
of valves of saphenous veins, intrinsic weakness of the vein wall, high
intraluminal pressure. Its incidence is 5% among Indian
population with more prevalence in women, obese and occupation that requires
prolong standing. Symptoms of varicose veins are dilated veins,
dragging pain, night cramps, pigmentation of skin, pedal edema, heaviness,
burning and itching sensation of lower limbs .
Intervention as per
contemporary science is Surgical and Non-surgical methods. Surgical
interventions includes stripping and ablation therapy. This may lead to
complications like infection, hematoma, etc. Non-surgical
interventions include elevation of limbs, compression stockings and
sclerotherapy. This may lead to complications like hyperpigmentation, allergic reactions to
sclerosants, etc with higher recurrence rate. Hence, it is the
need of hour to find effective treatment for the better relief and arrest the
further progression of the disease. In Ayurveda, Nidana
parivarjana, Shodhana, Shamana are the common line of protocol in the
management of disease. Snehayukta Virechana is explained as the
treatment in Vatarakta and Seka in Uttana
Vatarakta. As, many
works have been carried out on classical Virechana, Nitya Virechana and Seka
is selected in the present study. Hence, an effort is made to
know the combined effect of Nitya Virechana with Nimbamritadi
Eranda Taila, Dashamula Ksheera Kashaya Seka with internal administration
of Kokilakshadi Kashaya in the management of Uttana Vatarakta.
|