A Phase II Randomized Controlled Trial to Evaluate the Safety and Efficacy of Praneem Polyherbal Vaginal Tablets Compared With Betadine Vaginal Pessary in Women With Symptoms of Abnormal Vaginal Discharge

2009 ◽  
Vol 21 (4) ◽  
pp. 461-468
Author(s):  
Sudha Salhan ◽  
Vrijesh Tripathi ◽  
Raman Sehgal ◽  
Gaurav Kumar ◽  
Gursaran P. Talwar ◽  
...  
Keyword(s):  
Vaginal Discharge ◽  
Reproductive Tract ◽  
Controlled Trial ◽  
Lower Abdominal Pain ◽  
Phase Iii ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Vaginal Pessary ◽  
Abnormal Vaginal Discharge ◽  
Tract Infections

Abnormal vaginal discharge (AVD) caused by a variety of reproductive tract infections is a widespread syndrome among women in India and in other developing countries. The purpose of this study was to determine whether a polyherbal formulation, Praneem, can be used for the regression of the syndrome. A phase ΙΙ randomized controlled study was carried out with Praneem polyherbal tablets and Betadine vaginal pessary in 99 women with AVD. The authors found that 92% of women using Praneem were relieved of their symptoms of AVD as against 81.6% women using Betadine. Significant reduction was also seen with both treatments in lower abdominal pain, vaginal itching, and dysuria. Thus, the study indicates the efficacy of Praneem for the treatment of AVD and provides a rationale for planning a further Phase III study on a larger sample size for definitive conclusions.

scholarly journals HYPOfractionated Radiation Therapy Comparing A Standard Radiotherapy Schedule (Over Three Weeks) with A Novel One Week Schedule in Adjuvant Breast Cancer: An Open-Label Randomised Controlled Study (HYPORT- Adjuvant): Study Protocol for a Multicenter, Randomized Phase III Trial.

2020 ◽  
Author(s):  
Sanjoy Chatterjee ◽  
Santam Chakraborty ◽  
HYPORT Adjuvant Author Group
Keyword(s):  
Breast Cancer ◽  
Randomized Controlled Trial ◽  
Recurrence Rate ◽  
Adjuvant Radiotherapy ◽  
Locoregional Recurrence ◽  
Controlled Trial ◽  
Phase Iii ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Locoregional Recurrence Rate

Abstract Background Hypofractionated radiotherapy is the current standard for adjuvant radiotherapy across many centres. Further hypofractionation may be possible but remains to be investigated in non-caucasian populations with more advanced disease, with a higher proportion of patients requiring mastectomy as well as tumour bed boost. We are reporting the design of randomized controlled trial testing the hypothesis that a one week (5 fractions) regimen of radiotherapy will be non-inferior to a standard three week (15 fractions) schedule. Methods We describe a multicenter, randomized controlled trial recruiting patients at large academic centres across India. Patients without distant metastases who merit adjuvant radiotherapy will be eligible for inclusion in the study. Patients in the control arm will receive adjuvant radiotherapy to the breast or chest wall (with/without regional nodes) to a dose of 40 Gy / 15 fractions / 3 weeks, while those in the experimental arm will receive a dose of 26 Gy / 5 fractions / 1 week (to the same volume). Use of a simultaneous integrated boost (dose of 8 Gy and 6 Gy respectively) is allowed in patients who have undergone breast conservation. A sample size of 2100 patients provides an 80% power to detect a non-inferiority of 3% in the 5-year locoregional recurrence rate with a one-sided type I error of 2.5%, assuming that the locoregional recurrence rate in the control arm is 5% at 5 years (corresponding to a hazard ratio of 1.63). Patients will be recruited over a period of 5 years, and followed up for a further 5 years thereafter. Discussion If a five-fraction regimen of breast cancer is proven to be non-inferior, this will result in a significant improvement in the access to radiotherapy, as well as reduced costs of treatment. The trial gives an opportunity to standardize and quality assure radiotherapy practices across the nation at the same time. Along with the results of the FAST Forward trial, the safety of this intervention in advanced node-positive disease requiring regional nodal radiation will be established. Trial Registration The trial has been registered at the Clinical Trial Registry of India (CTRI) vide registration number: CTRI/2018/12/016816 (31/12/2018) as well as the clinical trial.gov website at NCT03788213 (28/12/2018).

scholarly journals HYPOfractionated Radiation Therapy comparing a standard radiotherapy schedule (over three weeks) with a novel one week schedule in Adjuvant breast cancer: An open-label randomised controlled study (HYPORT- Adjuvant): study protocol for a multicenter, randomized phase III trial.

2020 ◽  
Author(s):  
Sanjoy Chatterjee ◽  
Santam Chakraborty ◽  
HYPORT Adjuvant Author Group
Keyword(s):  
Breast Cancer ◽  
Randomized Controlled Trial ◽  
Recurrence Rate ◽  
Adjuvant Radiotherapy ◽  
Locoregional Recurrence ◽  
Controlled Trial ◽  
Phase Iii ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Locoregional Recurrence Rate

Abstract Background Hypofractionated radiotherapy is the current standard for adjuvant radiotherapy across many centres. Further hypofractionation may be possible but remains to be investigated in non-caucasian populations with more advanced disease, with a higher proportion of patients requiring mastectomy as well as tumour bed boost. We are reporting the design of randomized controlled trial testing the hypothesis that a one week (5 fractions) regimen of radiotherapy will be non-inferior to a standard three week (15 fractions) schedule. Methods We describe a multicenter, randomized controlled trial recruiting patients at large academic centres across India. Patients without distant metastases who merit adjuvant radiotherapy will be eligible for inclusion in the study. Patients in the control arm will receive adjuvant radiotherapy to the breast or chest wall (with/without regional nodes) to a dose of 40 Gy / 15 fractions / 3 weeks, while those in the experimental arm will receive a dose of 26 Gy / 5 fractions / 1 week (to the same volume). Use of a simultaneous integrated boost (dose of 8 Gy and 6 Gy respectively) is allowed in patients who have undergone breast conservation. A sample size of 2100 patients provides an 80% power to detect a non-inferiority of 3% in the 5-year locoregional recurrence rate with a one-sided type I error of 2.5%, assuming that the locoregional recurrence rate in the control arm is 5% at 5 years (corresponding to a hazard ratio of 1.63). Patients will be recruited over a period of 5 years, and followed up for a further 5 years thereafter. Discussion If a five-fraction regimen of breast cancer is proven to be non-inferior, this will result in a significant improvement in the access to radiotherapy, as well as reduced costs of treatment. The trial gives an opportunity to standardize and quality assure radiotherapy practices across the nation at the same time. Along with the results of the FAST Forward trial, the safety of this intervention in advanced node-positive disease requiring regional nodal radiation will be established. Trial Registration The trial has been registered at the Clinical Trial Registry of India (CTRI) vide registration number: CTRI/2018/12/016816 (31/12/2018) as well as the clinical trial.gov website at NCT03788213 (28/12/2018).

scholarly journals Reproductive tract infections associated with vaginal discharge and their socio-demographic and reproductive determinants among clinic attendees in Bangladesh

2013 ◽  
Vol 2 (2) ◽  
pp. 67-72
Author(s):  
Saifur Rahman ◽  
Marian J Currie ◽  
Robert F Breiman ◽  
Masud Reza ◽  
Motiur Rahman ◽  
...  
Keyword(s):  
Public Health ◽  
Bacterial Vaginosis ◽  
Trichomonas Vaginalis ◽  
Vaginal Discharge ◽  
Reproductive Tract ◽  
Reproductive Age ◽  
Reproductive Tract Infections ◽  
Reproductive Characteristics ◽  
Abnormal Vaginal Discharge ◽  
Tract Infections

Abnormal vaginal discharge is frequently associated with common sexually and non-sexually transmitted reproduc-tive tract infections (RTIs) and the resultant poor reproductive health outcomes. However, there is scarce informa-tion concerning the prevalence and etiologies of these infections in women in Bangladesh. The aim of study was to determine the rates of, and socio-demographic and reproductive characteristics associated with, common RTIs in urban public health clinics in Dhaka, Bangladesh. An urban clinic-based sample of 1309 currently married women of reproductive age presenting with abnormal vaginal discharge was recruited. Consenting women were interviewed and tested for Candida, bacterial vaginosis, Trichomonas vaginalis, Neisseria gonorrhoeae and Chlamydia tra-chomatis during a speculum examination. Approximately 53% (673/1309) of the participants had laboratory evi-dence of RTIs. The prevalence of Candida, bacterial vaginosis, T. vaginalis, N. gonorrhoeae and C. trachomatis were 32.4%, 22.4%, 3.1%, 2.1 %, 1.9% respectively. Age, education, living in a slum, working outside the home, polygamous marriage and suspecting infidelity were independently associated with vaginal and cervical infections. Candidiasis and bacterial vaginosis were the most common infections in this population. Paying attention to the socio-demographic and reproductive characteristics found to be associated with RTIs can assist clinicians in identi-fying women at risk of these infections. DOI: http://dx.doi.org/10.3329/seajph.v2i2.15958 South East Asia J Public Health | Jul-Dec 2012 | Vol 2 Issue 2 | 67-72

scholarly journals Women's perceptions and responses towards abnormal vaginal discharge: Focus Group Discussions in a socially marginalized community

2019 ◽  
Vol 71 ◽  
pp. 9-15
Author(s):  
IMPS Ilankoon ◽  
CSE Goonewardena ◽  
RC Fernandopulle ◽  
PPR Perera
Keyword(s):  
Health Care ◽  
Focus Group ◽  
Vaginal Discharge ◽  
Reproductive Tract ◽  
Cultural Practices ◽  
Cultural Influences ◽  
Focus Group Discussions ◽  
Group Discussions ◽  
Abnormal Vaginal Discharge ◽  
Tract Infections

Objective: Vulvo-vaginal discharge, which is a common gynaecological complaint, can be a normal phys- iological discharge or a symptom of an underlying reproductive tract infection, genital tract neoplasm, or other reproductive tract disorder. It is pertinent to differentiate physiological discharge from a pathological vulvo-vaginal discharge in order to prevent complications of untreated reproductive tract infections. Women are not seeking health advices for most of their gynaecological health issues and have different cultural practices to manage them. This study was conducted to explore the different cultural practices associated with vulvo-vaginal discharge among females aged 18–49 years living in an estate community in Colombo district, Sri Lanka. Methods: This descriptive qualitative study used three Focus Group Discussions (FGDs) with a total number of 20 women. Transcribed verbatim data were analyzed using qualitative content analysis. Results: Majority of the participants were Indian Tamils (n = 17, 85%) and Hindu (n = 15, 75%). Most (65%) of women were employed in the estate labour and educated up to grade 11 (n = 13). The major themes identified in the present study were difficulty in differentiating normal from abnormal vaginal discharge, lack of knowledge on causative factors, cultural influences and beliefs, unstable/limited source of income, fear of disclosing, and lack of support system. Many participants explained that they have difficulty in accessing health care as they are busy with their employment, household work, fear of internal examination, and fear of being admitted to the hospital ward. The common practice was to use home remedies such as polpala herbal drink (Balipoovu, Aerva lanata) or Neeramulliya (Asteracantha longifolia Linn) herbal drink, king coconut, Sauw (sago) Kanji, Uluhal (Fenugreek), and Aloe vera juice prior consulting medical advice for abnormal vaginal discharge. Conclusions: The findings of this study revealed the need of support for women in estate sector for their repro- ductive and sexual health matters. There is a high need of public health care worker’s guidance and counselling to overcome barriers for health care utilization in this community.

scholarly journals HYPOfractionated Radiation Therapy comparing a standard radiotherapy schedule (over three weeks) with a novel one week schedule in Adjuvant breast cancer: An open-label randomised controlled study (HYPORT- Adjuvant): study protocol for a multicenter, randomized phase III trial.

2020 ◽  
Author(s):  
Sanjoy Chatterjee ◽  
Santam Chakraborty ◽  
HYPORT Adjuvant Author Group
Keyword(s):  
Breast Cancer ◽  
Randomized Controlled Trial ◽  
Recurrence Rate ◽  
Adjuvant Radiotherapy ◽  
Locoregional Recurrence ◽  
Controlled Trial ◽  
Phase Iii ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Locoregional Recurrence Rate

Abstract Background: Hypofractionated radiotherapy is the current standard for adjuvant radiotherapy across many centres. Further hypofractionation may be possible but remains to be investigated in non-caucasian populations with more advanced disease, with a higher proportion of patients requiring mastectomy as well as tumour bed boost. We are reporting the design of randomized controlled trial testing the hypothesis that a one week (5 fractions) regimen of radiotherapy will be non-inferior to a standard three week (15 fractions) schedule.Methods: We describe a multicenter, randomized controlled trial recruiting patients at large academic centres across India. Patients without distant metastases who merit adjuvant radiotherapy will be eligible for inclusion in the study. Patients in the control arm will receive adjuvant radiotherapy to the breast or chest wall (with/without regional nodes) to a dose of 40 Gy / 15 fractions / 3 weeks, while those in the experimental arm will receive a dose of 26 Gy / 5 fractions / 1 week (to the same volume). Use of a simultaneous integrated boost (dose of 8 Gy and 6 Gy respectively) is allowed in patients who have undergone breast conservation. A sample size of 2100 patients provides an 80% power to detect a non-inferiority of 3% in the 5-year locoregional recurrence rate with a one-sided type I error of 2.5%, assuming that the locoregional recurrence rate in the control arm is 5% at 5 years (corresponding to a hazard ratio of 1.63). Patients will be recruited over a period of 5 years, and followed up for a further 5 years thereafter.Discussion: If a five-fraction regimen of breast cancer is proven to be non-inferior, this will result in a significant improvement in the access to radiotherapy, as well as reduced costs of treatment. The trial gives an opportunity to standardize and quality assure radiotherapy practices across the nation at the same time. Along with the results of the FAST Forward trial, the safety of this intervention in advanced node-positive disease requiring regional nodal radiation will be established.Trial Registration: The trial has been registered at the Clinical Trial Registry of India (CTRI) vide registration number: CTRI/2018/12/016816 (31/12/2018) as well as the clinical trial.gov website at NCT03788213 (28/12/2018).

Efficacy of Tamarindus indicus, Melia azadirach and Santalum album in syndromic management of abnormal vaginal discharge: A single-blind randomised controlled trial

2017 ◽  
Vol 15 (2) ◽  
Author(s):  
Tabasum Ali Bhat ◽  
Wajeeha Begum
Keyword(s):  
Abdominal Pain ◽  
Vaginal Discharge ◽  
Controlled Trial ◽  
Lower Abdominal Pain ◽  
Test Group ◽  
Control Group ◽  
Santalum Album ◽  
Syndromic Management ◽  
Abnormal Vaginal Discharge ◽  
Single Blind

Abstract Background At least 25 % of women attending genitourinary medicine (GUM) clinics receive treatment for one of the three common causes of abnormal vaginal discharge: bacterial vaginosis, candidiasis and trichomoniasis. Syndromic diagnostic approach was adopted by National AIDS Control Organisation (NACO) India, at the primary health centre level. Syndromic management implies the simultaneous treatment of two or more infections. The aim of this study was to assess efficacy of sandal sufaid, maghze tukhme bakayin and khaste tamar hindi in syndromic management of Sailanur rehm. Methods This study was a randomized, single blind, standard controlled trial. It was conducted to compare efficacy of formulation which contains buradae sandal safaid, safoofe maghze tukhme bakayin, safoofe khaste tamar hindi and safoofe shakkar safaid against combination of azithromycin, fluconazole and secnidazole on diagnosed subjects of Sailanur rehm. Test group received 10 g of test drug B.D for 21 days while control group received single dose of standard drug to both the partners. Vaginal symptom score (VSS) was used for assessing discharge and associated complaints. Visual analogous scale (VAS) was used for assessing low backache and lower abdominal pain. Results There were no significant differences between the two groups concerning baseline characteristics (p>0.05). VSS was significantly decreased with p<0.001 for both control and test group. VAS was significantly decreased with p<0.001 and p=0.07 in test and control group respectively for low backache. For lower abdominal pain p=0.006 for both groups after the completion of treatment. Conclusions The formulation can effectively alleviate the disease with associated symptoms without any side effects. It can be used in syndromic management of vaginal discharge. Future research is on large sample size.

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