| CTRI Number |
CTRI/2018/01/011171 [Registered on: 05/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
19/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the safety and efficacy of Arnophyte Cream in subjects with Herpes |
|
Scientific Title of Study
|
An open label, Phase II, Clinical Study to evaluate the efficacy and tolerability of Arnophyte Cream formulation for pain reduction in patients with recurrent genital herpes |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nimesh Mehta |
| Designation |
Principal Investigator |
| Affiliation |
Sai Medi centre |
| Address |
Sai Medi Centre, 55 B.D.D Chawl Worli Mumbai 400030
Mumbai
MAHARASHTRA
400030
India |
| Phone |
|
| Fax |
|
| Email |
drnimeshmehta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kavita Salkar |
| Designation |
Sr. Research Scientist |
| Affiliation |
Piramal Enterprises Limited |
| Address |
Piramal Enterprises Limited,
Phytomedicines department,
Second floor
Light Hall - A wing,
Saki Vihar Road, Chandivali,
Andheri - (E),
Mumbai.
Mumbai
MAHARASHTRA
400 072
India |
| Phone |
|
| Fax |
|
| Email |
kavita.salkar@piramal.com |
|
Details of Contact Person
Public Query
|
| Name |
Kavita Salkar |
| Designation |
Sr. Research Scientist |
| Affiliation |
Piramal Enterprises Limited |
| Address |
Piramal Enterprises Limited,
Phytomedicines department,
Second floor
Light Hall - A wing,
Saki Vihar Road, Chandivali,
Andheri - (E),
Mumbai.
Mumbai (Suburban)
MAHARASHTRA
400 072
India |
| Phone |
|
| Fax |
|
| Email |
kavita.salkar@piramal.com |
|
|
Source of Monetary or Material Support
|
| Piramal Enterprises Limited,
Light hall, Chandivali, ANheri east Mumbai 400072 |
|
|
Primary Sponsor
|
| Name |
Piramal Enterprises Limited |
| Address |
Light Hall - A wing,
Saki Vihar Road, Chandivali,
Andheri - (E),
Mumbai–400 072 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anirudh Tripathi |
Life Veda Treatment and Research Centre |
Dermal division, Room no.: 7/6, Century Quarters, Next To T.V. Tower, P.B.Road, Worli, Mumbai- 400030
Mumbai
MAHARASHTRA |
91-9820180084
dranirudh_t@yahoo.com |
| Dr Nimesh Mehta |
Sai Medi Centre |
Dermal division, Room no.: 55 B.D.D Chawl Worli Mumbai 400030
Mumbai
MAHARASHTRA |
9820487714
drnimeshmehta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Intersystem Biomedica Ethics Committee |
Approved |
| Intersystem Biomedica Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Early signs & symptoms of recurrent HSV-2, (1) ICD-10 Condition: B008||Other forms of herpesviral infections, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arnophyte Cream-Extract of Ficus arnotianna |
route: Arnophyte cream for topical application
duration: five times a day. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with at least one recurrence during the past 12 months and typically associated with ulcerative lesions (lesion which undergoes prodrome (pain, burning, itching ) vesicle, ulcer/soft crust and/or hard crust formation)
2. Male or female outpatient between the ages of 18- 60 years.
3. Females of child bearing age must have a negative pregnancy test and practice a reliable method of contraception (intrauterine device or combined contraceptives) for at least 3 months prior to enrollment visits and during the remaining study period
4. Patients must agree to abstain from the use of anti-inflammatory medications (including aspirin and NSAIDS), systemic steroids and analgesics during the treatment period until healing occurs
5. Patients must agree to abstain from the use of any topical treatments in the lesion area (e.g. moisturizers, herbal oils or herbal creams) during the treatment period until healing occurs
6. Patients must agree to abstain from any mechanical disruption of the prodromal area or lesion (i.e., scrubbing, lancing, shaving the area, rubbing with alcohol etc.)
7. Patients willing to give written and video informed consent and willing to follow up as per the protocol |
|
| ExclusionCriteria |
| Details |
1. Treatment or prevention with other systemic or topical antiviral agents; within 4 weeks prior to study drug administration
2. Immunodeficiency disorders such as HIV or receiving cancer chemotherapy
3. Previous herpes vaccine
4. Cytotoxic or immunosuppressive drugs, including systemic corticosteroids or steroids within 3 months, Fluorouracil or its pro-drugs, tricyclic antidepressants, probenecid, topical or systemic antiviral drugs or immunomodulatory agents for viral infection
5. Herpes zoster ophthalmicus, affecting mucous membrane oral cavity, complication of herpes zoster: visceral involvement, motor neuropathies, encephalitis, cerebrovascular complications, Severe disseminated infection: (more than 20 lesions outside the primary affected dermatome)
6. Clinical significant liver enzyme abnormalities and any other laboratory abnormalities determined by the screening lab
7. Pregnant, nursing and/or lactating females
8. Subjects with history of uncontrolled diabetes mellitus.
9. History of intolerance or hypersensitivity to the cream components
10. Significant skin disease (such as atopic dermatitis, eczema, psoriasis or chronic vesiculobullous disorders) that would interfere with assessment of lesions
11. Subjects receiving any systemic Ayurvedic, Homeopathic or Herbal drug; continuously for one month, three months prior to screening visit.
12. History or evidence from physical examination of tuberculosis
13. Unwillingness to refrain from using topical medical, OTC or cosmetic products in or around the genital area during the herpes recurrence. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effect of treatment on reduction of pain
Number of days of illness |
(Baseline/Day1, Day 2, 4, 7& 15) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. HSV-2, associated signs & symptoms
2. Lesion healing and size reduction
3. Physicians’ Global Assessment
4. Patients’ Global Assessment scale
5. The Changes in the Genital Herpes Specific Quality of Life.
6. Adverse Event
7. Rescue/Concomitant Medication |
(Day 1, 2, 4, 7 & 15)
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
17/02/2015 |
| Date of Study Completion (India) |
23/08/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
An Open Label, Phase II clinical trial was conducted at two sites. The treatment was given for a period of 14 days. The primary outcome measured in this trial was assessment of reduction in pain between baseline, day 2, day 4, day 7 and day 15, using the Visual Analogue Score (VAS). The changes in the Quality of Life Index for recurrent genital herpes (GHQoLr) were assessed on baseline, Day 4, Day 7 and Day 15; the physician’s global assessment and patient’s global assessment of the therapy will be performed on baseline, day 2, day 4, day 7 and day 15. Signs and symptoms associated with HSV-2, and healing of the target lesion were assessed using a lesion score, on baseline, day 2, day 4, day 7 and day 15. Results: Visual analogue score (VAS)
for pain was evaluated on baseline, day 2, day 4, Day 7 and Day 15. The mean VAS score at the baseline was 63.29
± 19.45 SD, which was reduced on day 15 visit to 24.66 ± 23.67 SD, showing
significant reduction in pain, p<0.0001. Complete pain reduction was noted
in 6 patients (15%) on or before 6 days of treatment,
and 20 patients i.e. 50% patients were relieved from pain at the end of Day 15.
Genital herpes quality of life (GHQoLr)
score reduced significantly after 15 days 14.83±8.98 SD as compared to the
baseline 33±2.30 SD, p <0.0001. During the treatment period the mean lesion
size was 1.65 cms at baseline, reduced to 1.34 cms on day 2 (p <0.0001),
which was significantly reduced to 0.75 cm, (p <0.0001), on day 7 which was
further reduced significantly to 0.34 cm, (p <0.0001), on day 15.
Overall Lesion specific score
significantly reduced from 14.55±2.19 SD baseline to 4.53±2.75 SD on Day 15, p
<0.0001, whereas tingling, vesiculation and ulceration were completely
reduced. The signs and symptoms like Erythema, itching and burning showed good
reduction i.e. >50%. There was no change found in the crusting of the
lesion. The physicians’ global assessment shows that 23 patients (57.5%)
patients showed improvement in the range of 75-99%.
The Patients’ global assessment shows that 29 patients (72.5%) showed
improvement in the range of 75-99%.
Treatment with the Arnophyte
cream application showed overall 4 adverse events; the adverse events were
common cold, diarrhoea, flatulence and pyrexia. These adverse events were not
related to study medication.
|