| CTRI Number |
CTRI/2024/08/072836 [Registered on: 21/08/2024] Trial Registered Prospectively |
| Last Modified On: |
09/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Leg Exercise Combined with Leg Massage Using Sahacharadi Taila Compared to Leg Exercise Alone in Early Stages of Varicose Veins
|
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Scientific Title of Study
|
Combined Effect of Lower Limb Exercise and Leg Massage With Sahacharadi Taila Compared to Lower Limb Exercise in Varicose Vein (CEAP 1&2): A Randomized Clinical Trial |
| 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 Prashant Patel |
| Designation |
PG Scholar |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Department of Shalya Tantra Amrita School of Ayurveda Vallikkavu Clappana Post
Kollam Kerala 690525
Kollam
KERALA
690525
India |
| Phone |
7359547236 |
| Fax |
|
| Email |
patelprashant6791@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajeshwari P N |
| Designation |
Professor And HOD |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Department of Shalya Tantra Amrita School of Ayurveda Vallikkavu Clappana Post
Kollam Kerala 690525
Kollam
KERALA
690525
India |
| Phone |
7760264692 |
| Fax |
|
| Email |
drrajeshwariphd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prashant Patel |
| Designation |
PG Scholar |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Department of Shalya Tantra Amrita School of Ayurveda Vallikkavu Clappana Post
Kollam Kerala 690525
Kollam
KERALA
690525
India |
| Phone |
7359547236 |
| Fax |
|
| Email |
patelprashant6791@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita School of Ayurveda
Vallikkavu Clappana Post
Kollam Kerala India 690525
|
|
|
Primary Sponsor
|
| Name |
Dr Prashant Patel |
| Address |
Department of Shalya Tantra
Amrita School of Ayurveda
Vallikkavu Clappana Post
Kollam Kerala 690525 |
| Type of Sponsor |
Other [Self] |
|
|
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 Prashant Patel |
Amrita Ayurveda Hospital |
Room number 3 OPD of Shalya Tantra Amrita Ayurveda hospital
Vallikkavu Clappana Post
Kollam Kerala 690525
Kollam
KERALA |
7359547236
patelprashant6791@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amrita School of Ayurveda |
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:I839||Asymptomatic varicose veins of lower extremities. Ayurveda Condition: SIRAJAGRANTHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | EkA~gga, à¤à¤•à¤¾à¤‚ग | (Procedure Reference: A.H.SU.2/8 , Procedure details: Leg massage with Sahacharadi taila and Lower limb exercise
Procedure:
• Participants will be instructed to lie down on the bed comfortably with both legs elevated.
• A participant will be instructed to heat the sahacharadi taila using the double boil method.
• In this method, take 10 ml of sahacharadi taila in a small bowl and place it in a larger bowl with hot water. The heat from the hot water warms the taila.
• Taila should be applied gently from the foot to above the knee for 10 minutes with the help of a bystander.
• After that participants will be instructed to do exercises like Toe stretching, Air cycling.
• First instructed toe stretching,
• Participants should be comfortably standing on their feet flat on the floor
• Lift toes to get them all to the same height.
• Hold for 3 seconds.
• Relax toes and lower them back down.
• Repeat 40 times in five minutes, with a one-minute break.
• Similar to that, but in the opposite way, such as lifting their heel off the ground
• Thus, the entire two-way exercise takes ten minutes.
• The second is Air cycling,
• Participants should be comfortably laid down on the bed
• Alleviate both legs up to 45 degrees
• Slowly, start moving legs as if cycling in the forward direction.
• Do one complete rotation 40 times in one minute, then take a short break and repeat 20 times in 20 minutes.
)
(1) Medicine Name: Sahacharadi Taila, Reference: A.H.CHI.21/67-69, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: bd, Duration: 2 Months | | 2 | Comparator Arm (Non Ayurveda) | | - | Lower limb exercise | Lower limb exercise:
• Participants will be instructed to do exercises like Toe stretching and Air cycling.
• First instructed toe stretching,
• Participants should be comfortably standing on their feet flat on the floor
• Lift your toes to get them all to the same height.
• Hold for 5 seconds.
• Relax your toes and lower them back down.
• Repeat 40 times in five minutes, with a one-minute break.
• Similar to that, but in the opposite way, such as lifting their heel off the ground
• Thus, the entire two-way exercise takes ten minutes.
• The second is Air cycling,
• Participant should be comfortably laid down on the bed
• Alleviate both legs up to 45 degrees
• Slowly, start moving your legs as if cycling in the forward direction.
• Do one complete rotation 40 times in one minute, then take a short break and repeat 20 times in 20 minutes.
|
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|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.CEAP classification C one and C two of varicose veins
2.Patient with Varicose vein in bilateral lower limb
3.Ability to participate in supervised exercise sessions.
4.Participants to perform leg massages with Sahacharadi Taila.
|
|
| ExclusionCriteria |
| Details |
1.History of deep vein thrombosis or other serious vascular diseases.
2.History of allergy to oil appliances
3.Patients with low back ache, Hip joint pain, and other morbidities who can not perform exercise
|
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Method of Generating Random Sequence
|
Stratified block randomization |
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Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess the improvement in pain using the VAS score
2. Improvement in Quality of Life using AVVQ & SF-36 |
both outcomes have Sem time points:
1st day,15th day,45th day,60th day of visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the changes in the distribution of Telangiectasias
2. To observe changes in skin thickness and intensity through Derma Lab Combo.
|
both outcomes have Sem time points:
1st day and 60th day of visit |
|
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Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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 3 |
|
Date of First Enrollment (India)
|
01/09/2024 |
| 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
|
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Brief Summary
|
Background Varicose veins (VV) are twisted dilated
elongated tortuous veins of the lower limb and have been considered a
cosmetic problem. However, varicosities may cause pain, loss of working days,
disability, and discomfort, and it adversely affects the health-related quality
of life (QoL). As per Acharya Sushruta and Vagbhata, the Varicose vein
can be correlated to “Sirajagranthi†and is described in the context of the
Granthi-apachi-arbuda-galaganda chapter. In Ashtanga Hridayam Chikitsa Sthana describes
Sahacharadi taila; the same formulation has been described in
Sahasrayogam as an external application. Sahacharadi taila is recognized for its anti-inflammatory and
rejuvenating qualities. Non-pharmacological treatments include exercise
training, which aims to enhance calf muscle pump function and is found to be a
beneficial therapy for varicose vein treatment. Purpose of the study The
purpose of this randomized clinical trial is to combine supervised lower limb exercise and leg
massage with Sahacharadi Taila can provide a comprehensive approach targeting
both the physical activity aspect and the potential benefits of massage.
The rationale for the study lies in the need to explore
a comprehensive and holistic approach to managing varicose veins in their early
stages, combining conventional exercise with traditional Ayurvedic leg massage,
and evaluating the potential benefits in terms of symptom relief, prevention of
progression, and improvement in overall quality of life.
|