| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | bandhanakarma, बनà¥à¤§à¤¨à¤•रà¥à¤® | (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 | | 2 | Intervention Arm | Procedure | - | bandhanakarma, बनà¥à¤§à¤¨à¤•रà¥à¤® | (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. |