FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:I838||Varicose veins of lower extremities with other complications. Ayurveda Condition: SIRAJAGRANTHIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-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
2Comparator ArmProcedure-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
 
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.  
 
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.

 
Close