A clinical study to evaluate the efficacy of manjistadi lepa in the management of superficial phlebitis

Phase 2/3

Not yet recruiting

• Conditions: Phlebitis and thrombophlebitis ofsuperficial vessels of lower extremities. Ayurveda Condition: SIRAGATAVATAH,

• Registration Number: CTRI/2025/04/084369
• Lead Sponsor: Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan

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](https://pubmed.ncbi.nlm.nih.gov/?term=Mandal%20A%5BAuthor%5D) and [K Raghu](https://pubmed.ncbi.nlm.nih.gov/?term=Raghu%20K%5BAuthor%5D)

        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)

Detailed Description

Not available

Study Timeline

• Study Start: 2025-04-18
• Last Update Posted: 2025-08-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 1.Clinical signs and symptoms of Superficial phlebitis as a result of injury.
• 2.Established cases of Superficial phlebitis in varicose veins.
• 4.Patients irrespective of all age group will be selected.

Exclusion Criteria

• 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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
EFFECTIVENESS OF MANJISTADI LEPA IN REDUCING THE SYMPTOMS OF SUPERFICIAL PHLEBITIS	1 WEEK

Secondary Outcome Measures

Name	Time	Method
EFFECTIVENESS OF MANJISTADI LEPA IN REDUCING THE SYMPTOMS OF SUPERFICIAL PHLEBITIS	3 WEEKS

Trial Locations

Locations (1)

Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital; 🇮🇳 Hassan, KARNATAKA, India

Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital

🇮🇳Hassan, KARNATAKA, India

Dr Priyanka J M

Principal investigator

9632544457

priyankajm2015@gmail.com