Health Condition 1: null- Low-grade Squamous Inter-epithelial Lesions/ High-grade Squamous Intra-epithelial Lesions in Pap smears in women
Conditions
Interventions
Intervention1: Holistic turmeric extract: Soft Gel Capsule of Holistic turmeric extract: 600 mg (Curcumin 200mg + Turmerone 200 mg + Polysaccharides 200 mg)
Dosage: 1 capsule twice daily after breakfa
Sponsors
Pharmanza Herbals Pvt Ltd product supply and financial support
Eligibility
Inclusion criteria
Inclusion criteria: 1 Women between 30 and 65 years of age 2 Women with LSIL or HSIL reported in Pap smear and confirmed by colposcopy as LSIL 3 Willing to follow the protocol and give written consent 4 Using effective nonhormonal method of contraception- eg.Tubal ligation 5 Willing to abstain during treatment with antimicrobials if not treated earlier (or use of condoms)- However if they have been treated for PID within 4 weeks, they will not be given initial antimicrobial therapy as they are already treated 6 Women with controlled Diabetes or hypertension or thyroid therapy or other mineral or vitamin therapy will not be excluded if they have had a steady dosage for past 3 months. They will be advised to keep an interval of one and a half hour between their medication and the intake of holistic turmeric extract.
Exclusion criteria
Exclusion criteria: 1 Women with higher grades of abnormality in Pap smear, or colposcopy, suspected of cervical cancer. 2 Unexplained bleeding, heavy or irregular menstrual bleeding 3 Uncontrolled systemic diseases like hypertension, heart disease, diabetes, jaundice etc. 4 Women with organic gynec pathology- fibroids, prolapse, ovarian tumours. 5 Women with abnormal clinical biochemistry, hemoglobin below 9 gms %, LFT > 2 SD. 6 Positive VDRL or HIV tests. 7 Pregnancy and lactation within 6 months 8 Women with allergy to dietary component- turmeric, or any drugs to be used in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pap smear which does not progress to HSIL, or which may regress at 6 weeks and 10 weeks Colposcopy Not exceeding LSIL (cervical intraepithelial neoplasia Grade I) Timepoint: Pap smear at 6 weeks and 10 weeks Colposcopy at 6 weeks and 10 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum IL-6 reductionTimepoint: 10 weeks | — |
Countries
India
Contacts
Public ContactDr Jayashree Joshi
Medical Research Center of Kasturba Health Society
Outcome results
None listed