CTRI/2025/04/085478 [Registered on: 23/04/2025] Trial Registered Prospectively
Last Modified On:
21/04/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug Ayurveda
Study Design
Single Arm Study
Public Title of Study
A clinical study to find out efficacy of Ayurveda treatment protocol on Dushta vrana (Non Healing wound)
Scientific Title of Study
Management of Dushtavrana WSR to Chronic Non-Healing Ulcers by using Guduchi Triphaladi Guggulu, Gandharva Haritaki Churna orally along with Lekhan Karma, Jaluaka Avacharan, Nimb Patra Kashay
Dhavana and Nimbadi ointment Local Application: A Single Arm Exploratory Study
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 Yogesh Badwe
Designation
Professor and Head, Department of Shalya Tantra
Affiliation
ALL INDIA INSTITUTE OF AYURVEDA, NEW DELHI
Address
Room No 502, 5th Floor, Department of Shalya Tantra, Academic Section, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi
South DELHI 110076 India
Phone
9011060498
Fax
Email
ayuryogeshbadwe@gmail.com
Details of Contact Person Scientific Query
Name
Dr Yogesh Badwe
Designation
Professor and Head, Department of Shalya Tantra
Affiliation
ALL INDIA INSTITUTE OF AYURVEDA, NEW DELHI
Address
Room no 502, 5th Floor, Department of Shalya Tantra, Academic Section, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi
DELHI 110076 India
Phone
9011060498
Fax
Email
ayuryogeshbadwe@gmail.com
Details of Contact Person Public Query
Name
Dr V D Mahanta
Designation
Associate professor, Department of Shalya Tantra
Affiliation
ALL INDIA INSTITUTE OF AYURVEDA, NEW DELHI
Address
Room no 503, 5th Floor, Department of Shalya Tantra, Academic Section, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi
South DELHI 110076 India
Phone
7838957972
Fax
Email
drvyasayu@gmail.com
Source of Monetary or Material Support
All India Institute of Ayurveda, New Delhi
Primary Sponsor
Name
All India Institute of Ayurveda, New Delhi.
Address
Department of Shalya Tantra, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi. 110076
Type of Sponsor
Research institution and hospital
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
Prof Dr Yogesh Badwe
ALL INDIA INSTITUTE OF AYURVEDA, NEW DELHI
IPD 3rd Floor, Hospital Block, Department of Shalya Tantra, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi. South DELHI
9011060498
ayuryogeshbadwe@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Institutional Ethics Committee, All India Institute of Ayurveda, New Delhi.
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition:L984||Non-pressure chronic ulcer of skin, not elsewhere classified. Ayurveda Condition: DUSHTAVRANAH,
Intervention / Comparator Agent
sno
Intervention/Comparator
Type
Drug-Type
Procedure Name
Details
1
Intervention Arm
Drug
Classical
(1) Medicine Name: Gudichi Triphaladi Guggulu, Reference: Sahasrayogam Parishistha Prakarana, Route: Oral, Dosage Form: Guggulu , Dose: 1(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Warm Water), Additional Information: Classical reference is Guduchi Triphaladi Kwath. Dosage form will be modified. Guggulu will be prepared by giving 7 Bhavana of Guduchi Triphaladi Kwath. Vati of 500mg will be prepared.
2
Intervention Arm
Drug
Other than Classical
(1) Medicine Name: Gandharv Haritaki Churna, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Warm Water), Additional Information: 10 gm churna will be administered daily for 28 days.
3
Intervention Arm
Procedure
-
kaShAyaH, कषायः
(Procedure Reference: Sushrut Samhita Chikisasthan Chapter 1, Procedure details: (Procedure Reference: Sushrut Samhita Chikitsa Sthan Adhyay 1, Procedure details: Vrana Dhavana will be done using the Nimba Patra Kashaya. Quantity of Kashaya will be used as per the size of the wound. The procedure will be done once per day.)) (1) Medicine Name: Nimba Patra Kashay, Reference: Kaiyadeva Nighantu, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 20(ml), Frequency: od, Duration: 28 Days
4
Intervention Arm
Procedure
-
leKana-karma, लेख़न-करà¥à¤®
(Procedure Reference: Sushrut Samhita Chikitsa Sthan Chapter 1, Procedure details: Lekhan Karma will be done on Day 0)
5
Intervention Arm
Procedure
-
kalkaH, कलà¥à¤•à¤ƒ
(Procedure Reference: Sushrut Samhita Chikitsa Sthana Adhyay 1, Procedure details: Modified dosage form of Kalka in the form of ointment will be applied over the wound surface once daily for 28 days.) (1) Medicine Name: Nimbadi ointment, Reference: Sushrut Samhita Chikitsa Sthana Adhyay 1, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 10(g), Frequency: od, Duration: 28 Days
(Procedure Reference: Sushrut Samhita Chikitsasthan Adhyay 1, Procedure details: 3 Leeches of Medium Size will be applied till healthy granulation will be achieved. (Maximum duration 4 weeks))
Inclusion Criteria
Age From
19.00 Year(s)
Age To
70.00 Year(s)
Gender
Both
Details
1) Age group between 19 to 70
2) Chronic non-healing ulcers (Diabetic Ulcer, Venous Ulcer, Traumatic Ulcer,
Burns)
ExclusionCriteria
Details
1) Patients with WBC count above 12000/mm3
2) Immunocompromised patients like HIV, HbsAg, HCV positive patients
3) Pressure sores
4) Known case of TB, Leprosy ulcer, Malignant Ulcers
5) Pregnant females
6) Uncontrolled Diabetes, Hypertension.
7) Hepatic and Liver Failure
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Reduction in wound size more than 50% of its original size or complete healing.
Day 0, Day 14, Day 28
Secondary Outcome
Outcome
TimePoints
1) Documentation of Antimicrobial activity of selected formulations.
2) Evaluation of Healing activity by Histopathological analysis of ulcer tissue,
VEGF-AA, Hydroxyproline Assay.
Day 0 Day 14 Day 28
Target Sample Size
Total Sample Size="50" Sample Size from India="50" 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/ Phase 3
Date of First Enrollment (India)
05/05/2025
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="0" 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
INTRODUCTIONA chronic non-healing ulcer is defined as an ulcer that is not healed by 40-50%
after four weeks of appropriate treatment.1
Treatment of Chronic Non-Healing ulcers
has always been a challenging task for surgeons. New treatment modalities are being
developed to treat such ulcers effectively.
Ayurveda has great potential in treating such conditions due to its
multidimensional approach. Sushrut Samhita, a surgical treatise of Ayurveda,
emphasizes on diagnosis and management of various types of ulcers. In Sushrut
Samhita, Shashti Upakramas i.e., 60 different treatment modalities are explained for
the treatment of ulcers. These modalities are to be used in specific phases of the process
of ulcer healing.2
Many factors are responsible for the non-healing of any type of ulcer. Some of
them are Lack of oxygenation, infections, systemic diseases like diabetes mellitus,
hypertension, lack of nutrition, Stress, etc.3
Ayurveda also has explained various reasons for delayed or non-healing of
ulcers like ulcers with pus discharge, foreign bodies, presence of poisonous substances
at the ulcer site, involvement of deeper structures, etc.4
The primary target in the treatment of chronic non-healing ulcers is the reinitiation of the healing process. It can be achieved by eliminating confounding factors
along with the promotion of the healing process. The treatment modalities like
Vranashodhana, Vranadhavana, Vranaropana along with Koshthashodhana can be
used to eliminate the confounders and re-initiate the healing process.
Sahasrayoga is a famous book of formulations traditionally used in Kerala. It
has many simple yet effective formulations indicated for several diseases. One such formulation named as Guduchi-Triphaladi Kashayam is indicated in skin diseases,
ulcers, and inflammations.5
It contains Guduchi (Tinospora cordifolia (Thunb.) Miers),
Triphala (combination of Terminalia chebula Retz., Terminalia bellirica
(Gaertn.)Roxb., Emblica officinalis Gaertn.), and Daruharidra (Berberis aristata DC).
The combination is to be used in decoction form along with Guggulu.
According to the principles of Ayurveda, Virechana is indicated in the treatment
of Chronic Ulcers6
. Gandharva Haritaki Churna, a simple combination of Erand Taila
and Haritaki Churna PO can do virechana on a daily basis. Additionally, Haritaki also
has Vranaropana property.7
To facilitate the healing of ulcer, absence of any necrotic tissue,
hypergranulation, fibrosed edges is important. To achieve that Surgical Debridement
of the ulcer is necessary. Sushruta also mentions this under the title Lekhan Karma.
A proper ulcer care regimen is an essential part of the treatment of ulcer healing.
One of the components of the ulcer care regimen is cleaning or washing the ulcer.
Antiseptic solutions are commonly used for this purpose. Sometimes de-sloughing
agents are also required. Nimba (Azadirachta indica) is a commonly available plant
traditionally used for ulcer care. It has antimicrobial as well as cleansing properties
making it a suitable agent for ulcer wash.8
Another component of the ulcer care regimen is the dressing material. Various
ointments, creams, medicated gauze, etc. are being used for dressing for decades. An
ideal dressing material should be antiseptic, should keep the ulcer area moist, and
should promote healing. Ayurveda texts have various formulations for the dressing of
ulcers. One such formulation, specifically mentioned for non-healing ulcers in Sushrut
Samhita Chikitsa- Sthan Chapter 1, is the paste of Nimba Patra Churna (Neem Leaf
powder), Tila Churna (Sesamum powder), Madhu (Honey) and Ghrita (Ghee). The combination is said to have Vranashodhana (Cleansing) and Vranaropana (Healing)
actions.9
Ayurvedic texts describe the qualities of Aushadha (Treatment) as Bahukalpa (Multiple
Modalities), Bahuguna (Multiple Actions), Sampanna (Of Superior Quality and Yogya
(Rightly Chosen). Also, Bheshaja is of three types- Antah-parimarjan (Internal), Bahiparimarjan (External)and Shastra-pranidhan (Surgical). Combination of these can give
better results in Chronic Non-Healing Ulcer. Keeping this in mind this study using a
set of internal and external medication along with a surgical (Lekhan Karma) and a
para-surgical (Jalauka Avacharan) procedure is proposed for the treatment of Chronic
Non-Healing Ulcer.
NEED OF STUDY-
Non-healing ulcers are a major health problem worldwide and needs a
multidimensional approach. Sometimes, intractable non-healing ulcers are inevitable
and detrimental to the lower limb and are a major cause of non-traumatic lower limb
amputations. It is estimated that 6% of the global population are afflicted by chronic
ulcers. It needs more holistic and integrated medical management for further
progression and to salvage the from social deprivation and financial burden.
The patients with Chronic non-healing ulcers (CNHU) needs timely intervention
with tissue debridement, topical antimicrobial, compression, Oxygenated blood
supply. Acharya sushruta has mentioned that Jaluaka/ leech is suitable device to
remove dushita Rakta and to supply oxygenated blood to affected part until normal
circulation can be restored. Pain relief from leech therapy is rapid, effective, and longlasting. Acharya Sushruta has also mentioned the importance of Lekhan Karma to
promote the healing of ulcers by removing the confounding factors like hypergranulation, fibrosed edges, etc. In addition to that Various Kalpas are given to
maintain the ulcer sterile and promote healing.
Guduchi Triphaladi Kashay (Guduchi, Triphala, Daruharidra) mentioned in
Sahasrayoga is a very simple yet completely unexplored formulation indicated in Tvak
Roga, Vrana and Shotha. It is to be taken along with Guggulu for period of 1 month.
Nimbadi Kalka (Nimba, Tila, Madhu, Ghrita) is mentioned in Sushrut Samhita. It
is indicated in Non-Healing Ulcers. Daily administration of Kashaya and Kalka can be a tedious job. To increase the
ease of administration and palatability, dosage form of the formulations will be
changed from Kashay to Kashay Bhavita Guggulu and Kalka to Ointment.
Many studies have been done to assess the antimicrobial as well as ulcer healing
activity of Nimba (Azadirachta indica), Tila (Sesamum indicum), Honey, and Ghee
independently.
One Study about the efficacy of Nimbadi Kalka (Nimba Tila Madhu Ghrita) in
Diabetic Foot Ulcers has been published10
.
The aim of this study is to evaluate the efficacy and duration of healing by utilizing
Lekhan Karm, Jalauka Avacharan (sterile medicinal leeches) nearer or over the ulcer
site, Guduchi Triphaladi Guggulu and Gandharv Haritaki Churn orally along with
Nimb Patra Kashay and Nimbadi ointment locally.
OBJECTIVE:
Primary Objective:
1) To evaluate the healing effect of Guduchi Triphaladi Guggulu, Gandharva
Haritaki Churna orally along with Lekhan Karma, Jaluaka Avacharan, Nimb
Patra Kashay Dhavana and Nimbadi ointment Local Application in the
management of Dushta Vrana WSR to Chronic Non-Healing Ulcer
Secondary Objective:
1) Study the antimicrobial activity of selected formulation.
2) To study the Histopathological analysis of ulcer tissue, VEGF-AA,
Hydroxyproline Assay.
STUDY DESIGNStudy Type- Single Arm Exploratory Study
Masking- Open Label
Study Centre- All India Institute of Ayurveda, New Delhi.
Sample Size- Minimum 50 patients.
DRUG DELIVERY REGIMEN AND POSOLOGY
Drug Route of
administration
Dose Duration
Lekhan Karma prior to
application of ointment
- - -
Guduchi Triphaladi
Guggulu
Oral 1 gm TDS 28 Days
Gandharv Haritaki
Churna
Oral 10 gm HS 28Days
Nimba Patra Kwatha Vrana Dhawan As per wound
size
28Days
Nimbadi Ointment Local Application As per wound
size
28 Days
Jalauka Avacharan Local Application 3 Leeches of
Medium Size
2 times/
week- till
healthy
granulation
is achieved.
(Max. up to
4 weeks.)
CLINICAL STUDYEnrolment of Patients
All the patients will be enrolled from Shalya Samanya OPD of All India Institute of
Ayurveda, New Delhi.
Inclusion Criterion
1) Age group between 19 to 70
2) Chronic non-healing ulcers (Diabetic Ulcer, Venous Ulcer, Traumatic Ulcer,
Burns)
Exclusion Criterion
1) Patients with WBC count above 12000/mm3
2) Immunocompromised patients like HIV, HbsAg, HCV positive patients
3) Pressure sores
4) Known case of TB, Leprosy ulcer, Malignant Ulcers
5) Pregnant females
6) Uncontrolled Diabetes, Hypertension.
7) Hepatic and Liver Failure
Investigations Prior To StudyCBC, RBS/FBS, PPBS, HbA1C, LFT, KFT, HIV, HBsAg, HCV, X-ray of relevant
part.
ASSESSMENT CRITERIASubjective Criteria1) Bates-Jensen ulcer assessment tool (On Day 0, Day 7, Day 14, Day 21, Day 28.)
Objective Criteria1) Ulcer Swab C/SDay 0, Day 7, Day 14,
2) Digital Ulcer assessment using Digital imaging and processing with Software
Image J (developed by NIH)
13 | Page
Day 0, Day 14, Day 28.
3) Histopathological Analysis of by Edge BiopsyDay 0, Day 14, Day 28.
4) Growth Factor – VEGF-AA using ELISA MethodDay 0, Day 14, Day 28.
5) Hydroxyproline Assay using ELISA MethodDay 0, Day 14, Day 28.
Withdrawal CriteriaThe patient will be withdrawn from the trial if1) The patient is willing to discontinue treatment.
2) The patient is showing the following symptoms-
- Core temperature > 38.30C or < 360C
- HR > 90 bpm
- Reduced Capillary Refill
- TLC > 12000/mm3
- Platelet Count < 1.0 Lakh/mm3
- INR > 1.5
Rescue TreatmentThe patient will be shifted to conventional treatment (protocol) after assessment.
PRIMARY END POINTReduction in wound size more than 50% of its original size or complete healing.
SECONDARY END POINTS1) Documentation of Antimicrobial activity of selected formulations.
2) Evaluation of Healing activity by Histopathological analysis of ulcer tissue,
VEGF-AA, Hydroxyproline Assay.