FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/04/084369 [Registered on: 08/04/2025] Trial Registered Prospectively
Last Modified On: 08/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive
Process of Care Changes 
Study Design  Randomized, Crossover Trial 
Public Title of Study   A clinical study to evaluate the efficacy of manjistadi lepa in the management of superficial phlebitis 
Scientific Title of Study   Clinical study to evaluate the efficacy of manjistadi lepa in the management of siragata vyadhi with special reference to superficial phlebitis  
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 Priyanka J M 
Designation  Post Graduate scholar 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan 
Address  Department of Shalya Tantra, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,B M Road, Thanniruhalla, Hassan

Hassan
KARNATAKA
573201
India 
Phone  9632544457  
Fax    
Email  priyankajm2015@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prasanna Narasimha Rao 
Designation  Professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan 
Address  Department of Shalya Tantra, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,B M Road, Thanniruhalla, Hassan

Hassan
KARNATAKA
573201
India 
Phone  9448064277  
Fax    
Email  profpnrao@sdmcahhassan.org  
 
Details of Contact Person
Public Query
 
Name  Dr Prasanna Narasimha Rao 
Designation  Professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan 
Address  Department of Shalya Tantra, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,B M Road, Thanniruhalla, Hassan

Hassan
KARNATAKA
573201
India 
Phone  9448064277  
Fax    
Email  profpnrao@sdmcahhassan.org  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital,B M Road ,Thanniruhalla,Hassan-573201,Karnataka,India  
 
Primary Sponsor  
Name  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan 
Address  Department of Shalya tantra, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,B M Road, Thanniruhalla, Hassan , karnataka, pincode-573201, India, Phone no- 0812256460, E-mail- sdmcah@gmail.com 
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 Priyanka J M  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital  DEPARTMENT OF SHALYA TANTRA ACADEMIC BLOCK 4 TH FLOOR SDM COLLEGE OF AYURVEDA
Hassan
KARNATAKA 
9632544457

priyankajm2015@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:I800||Phlebitis and thrombophlebitis ofsuperficial vessels of lower extremities. Ayurveda Condition: SIRAGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Manjistadi lepa, Reference: Sushruta Samhita , Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Clinical signs and symptoms of Superficial phlebitis as a result of injury.
2.Established cases of Superficial phlebitis in varicose veins.
3.Established cases of Superficial phlebitis at the site of canula insertion.
4.Patients irrespective of all age group will be selected. 
 
ExclusionCriteria 
Details  1)Patients with immunocompromised status like Human Immunodeficiency Virus and Hepatitis B positive and Tuberculosis.
2)Patients with Deep Vein Thrombosis
3)Patients with uncontrolled hyperglycemia (HbA1c more than 8percentile) 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
EFFECTIVENESS OF MANJISTADI LEPA IN REDUCING THE SYMPTOMS OF SUPERFICIAL PHLEBITIS   1 WEEK 
 
Secondary Outcome  
Outcome  TimePoints 
EFFECTIVENESS OF MANJISTADI LEPA IN REDUCING THE SYMPTOMS OF SUPERFICIAL PHLEBITIS   3 WEEKS  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   18/04/2025 
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   Not Applicable  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

AIMS AND OBJECTIVES:

To clinically evaluate the efficacy of the Manjistadi Lepa in the management of  superficial phlebitis.

METHODLOGY:

 

A. DIAGNOSTIC CRITERIA:        Diagnosis will be made on the basis of following features:

a.     Localised swelling

b.     Tenderness

c.     Redness  

d.     Increased local temperature  

e.     Fever (with or without)

f.      Cord like induration of veins  localized at cannula site (with or without)

 

 

B. SELECTION CRITERIA

INCLUSION CRITERIA

1)    Clinical signs and symptoms of Superficial phlebitis as a result of injury.

2)    Established cases of Superficial phlebitis in varicose veins .

                                 3)Established cases of Superficial phlebitis at the site of canula insertion

 

EXCLUSION CRITERIA:

               1)Patients with immunocompromised status like HIV,HBsAG and Tuberculosis.

                2)Patients with Deep Vein Thrombosis

                                  3)Patients with uncontrolled hyperglycemia (HbA1c>8 %)

 

ASSESSMENT CRITERIA

 

     The effect of therapy will be assessed by subjective and objective  parameters based on the clinical observation before and after treatment by grading.

 

 

SUBJECTIVE PARAMETERS:

A)Pain


 

OBJECTIVE PARAMETERS :

A)Swelling

B)Palpable venous cord

C)Erythema

D)Local raise in temperature

E)Tenderness 

 

 VIP SCORE – VISUAL INFUSION PHLEBITIS 

GRADES 

DETAILS

SIGNS

GRADE 0 

NO SIGNS OF PHLEBITIS

 

GRADE 1

POSSIBLY FIRST SIGN OF

PHLEBITIS

 

o SLIGHT PAIN AT IV SITE

OR SLIGHT REDNESS

GRADE 2 

EARLY STAGE OF

PHLEBITIS 

o PAIN AT IV SITE ,  o REDNESS,  o SWELLING 

GRADE 3

MEDIUM STAGE OF

PHLEBITIS

o     PAIN ALONG CANULA

PATH, 

o     REDNESS AROUND, o SWELLING

GRADE 4

ADVANCED STAGE OF

PHLEBTITIS

o PAIN ALONG CANULA

PATH, REDNESS

AROUND,  o SWELLING, o PALPABLE VENOUS

CORD 

GRADE 5

ADVANCED STAGE OF

PHLEBTITIS

o PAIN ALONG CANULA

PATH,  o REDNESS AROUND,  o SWELLING,  o PALPABLE VENOUS

CORD,  o PYREXIA

 

 TENDERNESS

GRADES 

DETAILS

GRADE 0 

NO PAIN

GRADE 1

TENDERNESS TO PALPATION WITHOUT GRIMACE OR FLINCH

GRADE 2

TENDERNESS WITH GRIMACE OR FLINCH

GRADE 3 

JUMP SIGN IS POSITIVE , WITHDRAWAL

GRADE 4 

WITHDRAWAL TO NON-NOXIOUS STIMULI ( SUPERFICIAL

PALPATION, PIN PRICK , GENTLE PERCUSSION)

 

 

 PAIN GRADING ACCORDING TO NRS SCALE 

RATING 

PAIN LEVEL 

0

NO PAIN 

1-3 

MILD PAIN ( NAGGING , ANNOYING , INTERFERING LITTLE

WITH ACTIVITIES OF LIFE ) -ADLs

4-6

MODERATE PAIN ( INTERFERES SIGNIFICANTLY WITH ADLs

7-10 

SEVERE PAIN ( DISABLING , UNABLE TO PERFORM ADLs)

 

 LOCAL TEMPRATURE ( IN COMPARISON TO NORMAL SURROUNDING SKIN )

 

GRADES  

DETAILS  

 

Grade 0  

Normal 

 

Grade 1  

 

Raised 

 

  SWELLING

 

GRADES  

DETAILS  

 

Grade 0  

Absent 

 

Grade 1  

Present 

 

 

 

 

 

 

 

STUDY DESIGN

The study will be open label single arm clinical study.

INTERVENTION (TREATMENT PLAN)

           Pre- operative / Poorva Karma   

        Informed consent will be taken from patient and patient party

        The patient is obtained into suitable position for the application of Manjistadi Lepa

        They will be then explained about the procedure

        Site of application will be cleaned properly

 

Operative procedures / Pradhana karma 

·       Freshly prepared Sheeta  Manjisthadi lepa(sheeta pradeha) is applied over the affected site in the Pratiloma Gati with a thickness of 0.4-0.8 cm (Ardra Maheesha Charma)

·       The Lepa is kept in situ till cracks were noted or till the patient complaines of

stretching sensation, i.e. before it dried completely.

 

Post-operative / Paschat karma

        After when Lepa gets dry, it will be cleaned with lukewarm water gently with cotton.

 

 

 

METHOD OF PREPARATION:

Sukshma Churna of all the above mentioned ingredients were taken in equal quantity in a bowl and Lepa was prepared by mixing it with cold water and this was applied to patients

 

Duration of the treatment:

Local application of Manjistadi lepa twice daily for 7 days or till the signs and symptoms resolves .  

 

 

Follow up study: 

After completion of treatment the patient will be asked to followed at an interval of  7 days twice to know if the signs and symptoms has resolved or not.

 

REFERENCES:

1. Sushruta Samhita; with Nibandha Sangraha commentary of Sri Dalhanacharya, & Nyachandrika Panjikacommentry of Gayadas; edited by Yadavji Trikumji Acharya; Chaukhamba Orientalia Varanasi; 7th Edition2002; Chikitsa sthana 3/47; pg 418 and 3/8; pg 415.

 

2. Sharangdhar: Virachitha Sharangadhara Samhita, Commentry by Dr.Smt.Shailaja Srivastava, Chaukhamba Orientalia Varanasi Uttarkhand, 11th Chapter, 1-2nd Sloka;

 

3. S. Das: Concise text book of surgery. Published by Dr. S. Das, 13 old Mayor’s court, Calcutta, India 700005. 3rd edition 2001. Pg No 68, 173, 212, 213.

 

4. SRB’s Manual of Surgery by Sriram Bhat, 2nd edition 2007, Jaypee publications, EMCA House 23/23B, Ansariroad, Daryagani. New Delhi.

 

5.Article-Utility of Manjistadi lepa in soft tissue inflammation by Dr Pallavi A.Hegde and Dr P.H Hemantha Kumar

         6. Study on incidence of phlebitis following the use of pherpheral intravenous catheter

                Abhijit Mandal and K Raghu

 

       7. A comprehensive review of Rubia cordifolia L.: Traditional uses, phytochemistry, pharmacological activities, and clinical applications

 

 

         8. Glycyrrhizin showed anti-arthritic and anti-inflammatory effect on formaldehyde induced rat paw edema. (Gujral et al, 1961a)

 

 

           9. The anti-inflammatory activity of Glycyrretic acid and its diacetate was similar to that of hydrocortisone. (Tangri et al, 1964)

       

   

           10. The anti-inflammatory response of Glycyrrhiza glabra was found to be equivalent    to that of oxyphenbutazone. It appeared to possess a more potent anti-pyretic and anti- exudative activity in comparison to oxyphenbutazone. (Saxema et al, 1970)

 
Close