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CTRI Number  CTRI/2024/08/072232 [Registered on: 09/08/2024] Trial Registered Prospectively
Last Modified On: 07/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) [wound dressing thechnique]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To See The Effect of Medicated Ghee (Manjistadi Ghrita) Prepared From Herbal Drugs In A Form Of Dressing Material (Sofra-Tulle/Vikeshika) In The Management Of Venous Ulcer  
Scientific Title of Study   An Open Label Randomized Controlled Clinical Study To Evaluate The Efficacy Of Manjistadi Ghrita Vikeshika And Jathyadi Ghrita Vikeshika In The Management of Dusta Vrana vis-a-vis Venous Ulcer. 
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 S Prarthana  
Designation  PG Scholar 
Affiliation  Rajiv Gandhi University Of Health Sciences,Banglore 
Address  Room No 10 Department Of PG and Ph.D Studies in Shalyatantra,JSS Ayurveda Medical College And Hospital, #41/E,Lalithadripura,Mysuru

Mysore
KARNATAKA
570028
India 
Phone  7337720229  
Fax    
Email  prarthanachummy633@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Poornima jalawadi 
Designation  Associate Proffesor 
Affiliation  JSS Ayurveda Medical And Hospital  
Address  Department Of PG and Ph.D Studies in Shalyatantra,JSS Ayurveda Medical College And Hospital, #41/E,Lalithadripura,Mysuru

Mysore
KARNATAKA
570028
India 
Phone  9663591100  
Fax    
Email  jalawadipoornim@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Poornima jalawadi 
Designation  Associate Proffesor 
Affiliation  JSS Ayurveda Medical And Hospital  
Address  Department Of PG and Ph.D Studies in Shalyatantra,JSS Ayurveda Medical College And Hospital, #41/E,Lalithadripura,Mysuru

Mysore
KARNATAKA
570028
India 
Phone  9663591100  
Fax    
Email  jalawadipoornim@gmail.com  
 
Source of Monetary or Material Support  
JSS Ayurveda Medical College And Hospital, #41/E,Lalithadripura,Mysuru-570028 
 
Primary Sponsor  
Name  Dr S Prarthana 
Address  Department Of PG And Ph.D Studies In Shalyatrantra, JSS Ayurveda Medical College, #41/E Lalithadripura, Mysuru -570028 
Type of Sponsor  Other [self] 
 
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 S Prarthana  JSS Ayurveda Medical College And Hospital  Department Of PG And Ph.D Studies In Shalyatrantra OPD, #41/E Lalithadripura, Mysuru -570028
Mysore
KARNATAKA 
7337720229

prarthanachummy633@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:I830||Varicose veins of lower extremities with ulcer. Ayurveda Condition: DUSHTAVRANAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-bandhanakarma, बन्धनकर्म (Procedure Reference: Bandana Vidhi Adhyaya sushrutha samhitha sutra sthana 18th chapter, Procedure details: The drugs like Jatipatra, Nimbapatra, Patolapatra, Katuki, Darvi, Nisha, Sariva, Manjishta,Abhaya, Madhuka, Shuddha tuttha, Sikta, Karanja beeja, Go-ghrita.The drugs mentioned will be taken in equal quantity with double the quantity of Ghrita then four parts of water will be added to it & shall be cooked on mild heat until it attains Ghritapaka siddhi lakshana .The Ghrita will be filtered and after cooling it will be stored in air tight container. UV Sterilized clean leno-weave fabric gauze of 10 ×10 cm size will be taken. It will be impregnated with Manjistadighrita/Jathyadighrita uniformly. Thus prepared vikeshika will be kept in between layers of sterilized silver foil and sterilized butter paper in order to prevent leakage of ghritha.Then it will be kept inside sterilized silver foil pouch ,sealed and stored in cool temperature. )
(1) Medicine Name: Jathyadi Gritha , Reference: Astanga Hridyam, Route: Topical, Dosage Form: Ghrita, Dose: 5(ml), Frequency: od, Duration: 28 Days
2Intervention ArmProcedure-bandhanakarma, बन्धनकर्म (Procedure Reference: bandhana vidhi adhyaya sushrutha samhitha sutra sthana 18th chapter, Procedure details: The drugs from Priyangvadi, Ambasthadiand Nyagrodadhi gana as mentioned in Dravya Sangrahniyam Adhyaya .The following seven drugs were selected for this study Manjista (Rubia cordifolia ).Daruharidra(Berberis aristata).Mocha rasa (Salmaliamalabarica).Dhatakipushpa (Woodfordiafruticosa).Madhuka (Madhuka longifolia).Lodhra(Symplocousracemosa).Rasanjana (Extract of Berberis aristata). The drugs mentioned will be taken in equal quantity with double the quantity of Ghrita then four parts of water will be added to it & shall be cooked on mild heat until it attains Ghritapaka siddhi lakshana .The Ghrita will be filtered and after cooling it will be stored in air tight container. UV Sterilized clean leno-weave fabric gauze of 10 ×10 cm size will be taken.It will be impregnated with Manjistadighrita/Jathyadighrita uniformly.Thus prepared vikeshika will be kept in between layers of sterilized silver foil and sterilized butter paper in order to prevent leakage of ghritha.Then it will be kept inside sterilized silver foil pouch ,sealed and stored in cool temperature. )
(1) Medicine Name: Manjistadi Ghrita, Reference: Dravya Sangarahniya Adhyaya Sutra Sthana 38th Chapter, Route: Topical, Dosage Form: Ghrita, Dose: 5(ml), Frequency: od, Duration: 28 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1)Irrespective of gender, religion and occupation.
2)Diagnosed cases of venous ulcer within 5cm× 5cm
size.
3)Controlled Diabetes Mellitus. Subjects fulfilling the Diagnostic criteria
 
 
ExclusionCriteria 
Details  1)Subjects suffering from systemic illnessess like uncontrolled Diabetes mellitus, uncontrolled Hypertension.
2)Infectious diseases like TB, HIV, Hepatitis-B, Leprosy, syphillis.
3)Malignant ulcers.
4)Peripheral Arterial Disease(PAD).
5)Subjects suffering from Gangrene,Burns and Sepsis.
6)Pregnant and Lactating women.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Subjects are assessed on the basis of subjective and objective parameters.
SUBJECTIVE PARAMETERS:
1)Pain.
2)Burning sensation.
3)Itching.
OBJECTIVE PARAMETERS:
1)Size of the wound.
2)Discharge.
3)Number of days taken for ulcer to heal.
4) Granulation tissue.

 
1st,7th,14th,21st,28th day 
 
Secondary Outcome  
Outcome  TimePoints 
Subjects are assessed on the basis of subjective & objective parameters.
SUBJECTIVE PARAMETERS:
1)Pain.
2)Burning sensation.
3)Itching.
OBJECTIVE PARAMETERS:
1)Size of the wound.
2)Discharge.
3)Number of days taken for ulcer to heal.
4) Granulation tissue.

 
5th,11th,15th,19th,25th. 
 
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   N/A 
Date of First Enrollment (India)   20/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/08/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
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  

Venous leg ulcers(VLUs) are common wounds that can deeply affect patient quality of life, which is challenging to healthcare systems due to its chronicity, non–healing in  nature.The high rate of recurrence (50-70%) can lead to longer term psychosocial effects, such as depression,anxiety,self-esteem issues and a decreased quality of life.VLUs are the most commonest ulcers found among chronic leg ulcers.70 to 90% of chronic leg ulcer is of venous origin. If this ulcer left untreated or not properly treated, they can lead to cellulitis, gangrene and even amputation of the affected limb. India has high prevalence rate of 4.5 cases per 1000 population in a year.The overall incidence is higher for females than males, although the exact number is hard to establish as it depends on the cohort and place of study.The VLU’S are non-healing in nature and most commonly seen in medial and lateral aspect of the ankleregion (gaiter’s zone).

The standard care for VLUs relies on conservative treatment and wound management. Conservative treatment includes compression therapy and supportive measures(physical therapy,manual lymphatic drainage, phlebotonics for symptom relief). Regarding direct ulcer interventions,like cleansing, debridement, infection control, applications of dressings and topical substances are in practice(5). Other approaches include sclerotherpy, surgicalprocedures, endovenous ablation techniques which are invasiveprocedures,expensive,chances of recurrence and can decrease the quality of life.

The wound dressings maintain adequate moisture, offer physical protection, promote granulation and re-epithelization but the  management of chronic venous ulcers is a challenging one(6). There  are numerous types of sterilized, packed dressing materials like semi-permeable film dressings, semi-permeable foam dressings, sofra tulle dressings, fixation sheets, alginate dressings, hydrocolloid and hydrogel dressings available in the market.Dressing selection is another key consideration in the VLU management. Appropriate dressings can perform in conjunction with compression therapy while also minimizing dressing related pain and trauma and avoiding unnecessary dressing changes ,in which all contributes to a better quality of care,an improved quality of life and restore patient confidence.

Hence for the standardization, advancement and betterment  in the field of dressing methodology without altering the basic principles, here an attempt is being made to prepare Manjistadi Ghrita Vikeshika using leno weave non absorbent gauze impregnated with Manjistadighrita with standard size, sterilized and sealed in a pack which might be an innovative contribution in the field of vrana management in Ayurveda.

Sample size :                                         

40 subjects selected for the study will be randomly (by lottery method) allocated and divided into 2 groups

GROUP - A:  20 subjects will be applied with ManjistadighritaVikeshika.

GROUP - B:  20 subjects will be applied with JathyadiGhritavikeshika.

Observational Period:  Dressing will be done everyday and weekly observations will be noted i.e on-before treatment,7th, 14th, 21st and on 28th day.

Study duration :28 days.

Follow up Period: 35th day and 42nd day.

Preparation Of Vikeshika:

The drugs mentioned will be taken in equal quantity with double the quantity of  Moorchitha Ghrita then four  parts of water will be added to it and shall be  cooked on mild heat until it attains Ghritapaka siddhi lakshana .The Ghrita will be filtered and after cooling it will be stored in air tight container.

UV  Sterilized clean leno-weave  fabric gauze of 10 ×10 cm size will be taken.

It will be impregnated with Manjistadi ghrita/Jathyadi ghrita uniformly.

Thus prepared vikeshika will be kept in between layers of  sterilized silver foil and sterilized butter paper in order to prevent leakage of ghritha. Then it will be  kept inside sterilized silver foil pouch ,sealed and stored in cool temperature.

 
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