| CTRI Number |
CTRI/2025/03/082297 [Registered on: 13/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative study to evaluate the efficacy of Atasi Upanaha and Yavaadi Upanaha with internal administration of Kaishora Guggulu in the management of Varicose Veins |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study to evaluate the efficacy of Yavaadi Upanaha and Atasi Upanaha with internal administration of Kaishora Guggulu in the management of Siraja Granthi with special reference to Varicose Veins. |
| 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 Anjana Ramachandra Pujar |
| Designation |
PG Scholar Shalyatantra |
| Affiliation |
BVVS Ayurveda Medical College and Hospital Bagalkot Karnataka |
| Address |
Department of PG Studies in Shalyatantra BVVS Ayurveda Medical College and Hospital BVVS Campus Bagalkot
Bagalkot KARNATAKA 587101 India |
| Phone |
9480411195 |
| Fax |
|
| Email |
anjanapujar369@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Pallavi A Hegde |
| Designation |
Professor |
| Affiliation |
BVVS Ayurveda Medical College and Hospital Bagalkot Karnataka |
| Address |
Department of PG Studies in Shalyatantra BVVS Ayurveda Medical College and Hospital BVVS Campus Bagalkot
Bagalkot KARNATAKA 587101 India |
| Phone |
9448636321 |
| Fax |
|
| Email |
drpallaviah@rediffmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Mallikarjun S Hiremath |
| Designation |
Professor |
| Affiliation |
BVVS Ayurveda Medical College and Hospital Bagalkot Karnataka |
| Address |
Department of PG Studies in Rachana Sharira BVVS Ayurveda Medical College and Hospital BVVS Campus Bagalkot
Bagalkot KARNATAKA 587101 India |
| Phone |
9482631399 |
| Fax |
|
| Email |
malikdost4u@gmail.com |
|
|
Source of Monetary or Material Support
|
| BVVS Ayurveda Medical College and Hospital, India, Bagalkot, Karnataka 587101 |
|
|
Primary Sponsor
|
| Name |
BVVS Ayurveda Medical College and Hospital |
| Address |
BVVS Ayurveda Medical College and Hospital BVVS Campus Bagalkot Karnataka 587101 |
| 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 Anjana Ramachandra Pujar |
BVVS Ayurveda Medical College and Hospital Bagalkot |
Department of PG Studies in Shalyatantra BVVS Ayurveda Medical College and Hospital BVVS Campus Bagalkot 587101 Bagalkot KARNATAKA |
9480411195
anjanapujar369@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BVVS Ayurveda Medical College and Hospital Bagalkot |
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:I838||Varicose veins of lower extremities with other complications. Ayurveda Condition: SIRAJAGRANTHIH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | upanAhasvedaH (sAgniH, उपनाहस्वेदः (साग्निः) | (Procedure Reference: Astanga Hrdaya, Uttarastana, Procedure details: Yavaadi Upanaha paste of thickness approximately 3-5mm (Ardramahishacharma) will be applied over the affected part of leg in upward direction when it is lukewarm & it will be covered with Eranda patra and firmly bandaged with cotton roll. Upanaha will be retained for 12 hours, then it will be removed and the part will be cleaned with lukewarm water.) (1) Medicine Name: Yavaadi Upanaha , Reference: Sushruta Samhita, Chikitsa Sthana, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 00(NA), Frequency: od, Duration: 7 Days(2) Medicine Name: Kaishora Guggulu, Reference: Sarngadhara Samhita, Madhyama Khanda, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: tds, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | upanAhasvedaH (sAgniH, उपनाहस्वेदः (साग्निः) | (Procedure Reference: Astanga Hrdaya, Uttarastana, Procedure details: Atasi Upanaha paste of thickness approximately 3-5mm (Ardramahishacharma) will be applied over the affected part of leg in upward direction when it is lukewarm & it will be covered with Eranda patra and firmly bandaged with cotton roll. Upanaha will be retained for 12 hours, then it will be removed and the part will be cleaned with lukewarm water.) (1) Medicine Name: Atasi Upanaha , Reference: Dr. Shobha G Hiremath, Textbook of Bhaisajyakalpana, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 00(NA), Frequency: od, Duration: 7 Days(2) Medicine Name: Kaishora Guggulu , Reference: Sarngadhara Samhita, Madhyama Khanda, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: tds, Duration: 7 Days |
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria:
1.Diagnosed patients of Siraja Granthi (Varicose Veins) in lower limbs.
2.Patients of either gender between 20 years to 70 years of age.
3.Patients of varicose vein with the Grading of clinical sign from 0-4a3. |
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
1.Patients with Uncontrolled Diabetes mellitus, Hypertension and Tuberculosis.
2.Varicose veins associated with complications like deep veins thrombosis and
venous ulcer.
3.Patients suffering from congenital varicose veins, secondary varicose veins due
to Tumor and Ascites.
4.Pregnant & Lactating women.
5.Infectious diseases like RVD and HBsAg. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To know the efficacy of Yavaadi Upanaha and Atasi Upanaha with internal administration of Kaishora Guggulu in the management of Siraja Granthi with special reference to Varicose Veins |
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Aim:
1.To compare the efficacy of Yavaadi Upanaha and Atasi Upanaha with internal
administration of Kaishora Guggulu in the management of Siraja Granthi with
special reference to Varicose Veins.
Objectives:
1.To evaluate the efficacy of Yavaadi Upanaha with internal administration of
Kaishora Guggulu in the management of Siraja Granthi with special reference
to Varicose Veins.
2.To evaluate the efficacy of Atasi Upanaha with internal administration of
Kaishora Guggulu in the management of Siraja Granthi with special reference
to Varicose Veins. |
7 Days |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
24/03/2025 |
| 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
|
Siraja Granthi is one of the Granthi Roga described in Ayurvedic Samhitas. The person’s who is weak, indulging in more of physical exercise, Vata get aggravated, invades the network of blood vessels causing Sampeedana, Sankochana and Vishoshanam and produce Granthi formation in Sira, this condition is called as Siraja Granthi. Siraja Granthi is non-pulsatile. By similarity in clinical features Siraja Granthi can be correlated with varicose veins, as varicose veins are dilated, tortuous and elongated veins in the leg. In varicose vein there is reversal of blood flow through its faulty valves. This occurs frequently in the superficial venous system of the lower limbs, resulting in varicose veins of lower limbs, he prevalence of trunk varicosities in the age groups 18-24 years, 25-34 years, 35-44 years, 45-57 years and 55-64 years was 11.5%, 14.6%, 28.8%, 41.9% and 55.7% respectively. It is a painful condition, so it hampers day to day activities of the person. Most people consider them more of an unsightly cosmetic inconvenience. Women are affected more frequently than men. Varicose veins may eventually reach five times their usual size if left to develop for long enough. Venous eczema, venous pigmentation, lipodermatosclerosis, superficial thrombophlebitis and venous ulceration are commonly observed complications of varicose veins. The treatment for varicose veins in modern science includes use of elastic compression stockings, sclerotherapy and surgical treatment. Acharya Vagbhata explained about Chikitsa of Siraja Granthi as internal administration of Sahacharadi Taila, application of Upanaha, Basti with Vata Shamaka Dravyas and Siravyadha. Upanaha is a type of Swedana, so it induces hyperthermia which improves local blood and lymphatic circulation and thereby improving local tissue metabolism, reduces inflammation by modifying secretion of various inflammatory mediators, relaxes local musculature by physical effect of heat and thereby reduces pain and increases the rate of trans-dermal drug delivery. In Upanaha, Bandha have added benefits, it indirectly provides firm support and relieves the muscle strain. In Siraja Granthi, Vata along with Shonita are vitiated, which are responsible for Sampidana (Pain), Sankocana (Constriction), Vakri (Distortion), and Vishosya (Drying up). Upanaha is mainly indicated in Vata Vikaras. The Upanaha should be applied to the area which presents with Kunchyamanam (contracted), Ruja (painful), Gatrastabdhata (stiffness) and firmly bandaged with Patta or Kshouma or Karpasa. As Siraja Granthi is also Dhatugata Vikara, hence Upanaha is considered for its management. Yavaadi Upanaha is explained in the treatment of Vatarakta in Mahavatavyadhi Chikitsitam Adhyaya in Chikitsasthana of Sushruta Samhita. Its ingredients are Yava, Madhuka, Eranda, Tila and Varshabhu which has properties of Vatahara, Shoolahara, Shothahara, Varnya, Shonita Vikarahara, Balakar, Stairyakara. The ingredients of Atasi Upanaha are, Atasi churna, Godhuma churna, Haridra churna, Tila tail and Saindhava lavana, which have the properties of Shoolahara and Shophahara. According to Sarangadhara Samhita in the context of Gutika Kalpana, Kaishora Guggulu is used in Vatarakta. Hence, the present study is undertaken to evaluate the efficacy of Yavaadi Upanaha and Atasi Upanaha with internal administration of Kaishora Guggulu in the management of Siraja Granthi with special reference to Varicose Veins. |