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While Bollywood is infamous for the rabid anti Hindu films continuously churned out by them, which, most believe are causing their films to bomb at the box office, the other film industries are also not far behind in exhibiting such paranoia as far as the Hindus are concerned. The primary defaulter on that count is the Bengali film industry.

One may question the Censor Board for permitting such a rabid Hindumisic film to pass through their scissors. However, according to a report by the online portal of Zee 24 Ghanta dated August 22, 2022, renowned fashion designer, Agnimitra Paul, who is a member of the Censor Board in Kolkata and currently and currently a Bengal BJP MLA, had not given her consent to the release of a film filled with such a violent and negative portrayal of the rural Hindus of Bengal. However, the film, which was made a couple of years back, stars Babul Supriyo in a pivotal role. He was a Central Minister at that time and had used his clout to get the film passed by the Censor Board. The singer cum actor is now a minster of the TMC-led government of West Bengal, having witched loyalties after being dropped from the Central Ministry in 2021. ( -dharmajudha-and-bismillah-lokkhi-chhele-can-be-next-target-of-boycott-trend-in-tollywood_441044.html).

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Boswellin Super is a standardized extract of Boswellia serrata Roxb gum resin, standardized to contain 30% 3-acetyl-11-keto-β-boswellic acid along with other β-boswellic acids (BSE). A randomized, double-blind, placebo-controlled clinical trial was conducted at two doses of BSE to understand its safety and efficacy in supporting joint health and improving mobility and symptoms of osteoarthritis (OA) of the knee.

Based on the inclusion/exclusion criteria, 105 newly diagnosed participants with degenerative hypertrophy OA were recruited and randomized into Placebo, BSE-150 mg or BSE-300 mg (n = 35 in each group) to receive either 150 mg or 300 mg BSE or a placebo tablet twice a day for 90 days. All the participants were evaluated for pain and physical function using the standard tools including the Visual Analog Scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lequesne Functional Index (LFI), EuroQol- 5 Dimension (EQ-5D) quality of life, 6-min walk test at day 0, days 5, 30, 60 and 90 of treatment. Additionally, the circulating levels of inflammatory biomarkers, tumor necrosis factor-α (TNFα), high-sensitive C-reactive protein (hs-CRP), and interleukin-6 (IL-6) were evaluated. Safety was evaluated by blood biochemical, hematological analysis, urinary analyses and by monitoring adverse events throughout the study.

Although OA affects all joints, it is most common in knee and hip joints. It is characterized by the degradation of articular cartilage leading to fibrosis, joint degeneration, and damage to the entire articular surface (Felson, 2004). The primary focus of OA management is to reduce pain using nonsteroidal anti-inflammatory drugs (NSAIDs) and specific cyclooxygenase II (COX-2) inhibitors (Wright, 2002). These drugs are known to be associated with gastrointestinal, renal, and cardiovascular risks (Singh, 1998; Harirforoosh et al., 2013). Thus, there is a need for an effective alternate therapy that can reduce the use of these drugs or complement their use with minimal adverse side effects.

Boswellic acids (BAs), the triterpenes present in the gum resins of B. serrata Roxb. (Family: Burseraceae) have been traditionally used in the Ayurvedic system of medicine as an antioxidant and anti-inflammatory agent to manage diseases such as rheumatoid arthritis, chronic bronchitis, asthma and chronic inflammatory bowel diseases and OA (Basch et al., 2004; Ahmed et al., 2013; Majeed et al., 2020a). The β-pentacyclic triterpene acids in Boswellia serrata including 3-acetyl-11-keto-β-boswellic acid (AKBBA), 11-keto-β-boswellic acid (KBBA), β-boswellic acid (BBA), and 3-acetyl-β-boswellic acid (ABBA), represent the major bioactive boswellic acids in the gum resin (Bchele et al., 2003; Poeckel and Werz, 2006). Amongst these boswellic acids, AKBBA was found to be a potent inhibitor of leukotriene-mediated inflammatory pathways and 5-lipoxygenases (5-LO) activities (Sailer et al., 1996; Schweizer et al., 2000). It has been shown to inhibit inflammatory mediators, matrix metalloproteins, and other adhesion factors in in vitro studies (Roy et al., 2005; Syrovets et al., 2005; Roy et al., 2006; Majeed et al., 2021). In a meta-analysis including seven clinical trials involving 545 patients, Boswellia and its extract were reported to have a positive effect on relieving pain, and stiffness and improving joint function (Yu et al., 2020). We have earlier reported the beneficial effect of Boswellin Super, a standardized extract of B. serrata containing not less than 30% 3-acetyl-11-keto-β-boswellic acid along with other β-boswellic acids, in an experimental collagen-induced preclinical arthritis model (Majeed et al., 2021). The preclinical safety of this compound has also been established as per the regulatory requirements (Majeed et al., 2020b). In the present study, we evaluated the clinical effects of Boswellin Super in a randomized double-blind placebo-controlled study as a standalone supplement in individuals with mild to moderate degenerative hypertrophy osteoarthritis.

Based on an earlier publication on B serrata extract, using 80% power and alpha = 0.05 significance level assuming a correlation of 0.2, the required total sample size was calculated as 90 for evaluation. Allowing for a 15% drop-out rate, the required sample size for recruitment was fixed at 105 in a 1:1:1 ratio between three arms. (Majeed et al., 2019). The details of the calculations are given in the supplementary section.

Individuals with degenerative hypertrophy OA with Kellgren-Lawrence (KL) grades I-II based on an X-ray of the knee joint and anteroposterior view on standing were enrolled in the study. The participants had pain perception ranging from 30 to 100 in the Visual Analog Scale (VAS). Other inclusion criteria were willingness to comply with the study protocol and attend regular follow-up visits. All the participants signed the written informed consent form.

The participants were excluded if they had nondegenerative joint diseases that can interfere with the evaluation of OA (Rheumatoid arthritis, active gout, recent joint trauma, or joint infection), KL grade of III or higher, incapacitated or bound to wheelchair or bed and unable to carry out self-care activities and those with a history of knee or hip replacement surgery. Participants with prior treatment with corticosteroids, glucosamine, chondroitin, hyaluronate, glucocorticoids, NSAID or steroids, and herbal or alternate medicines within 1 month before screening, were also excluded from the study. Other exclusion criteria were the presence of chronic diseases and hypersensitivity to herbal extracts or dietary supplements. Detailed exclusion criteria are given in the supplementary section.

The randomization sequence was prepared by an independent statistician, independent of the sponsoring organization and the investigators. Subjects were randomized using a predetermined block randomization schedule generated using computer-based randomization software (SAS 9.3). The study followed a double-blind design, wherein neither the investigator nor the subjects were aware of the treatment assignment. The principal investigator used randomly generated alphanumeric codes to refer to each of the investigational products. The randomization codes were kept strictly confidential and were accessible only to authorized persons on an emergency basis as per the standard operating procedures until the time of unblinding.

The investigational products (IP) of all three arms were manufactured, packaged, and stored in identical bottles to ensure proper blinding such that neither the investigator nor the subjects would be able to identify the dispensed IP to be an active or a placebo. All three tablets were coated with the same color to mask the identity and smell of the product. The subjects were trained to self-administer the IP at their home during the study period. They were asked not to open the IP bottles or discuss the color, nature, odor, or any description of the product. Further, the products were labeled using an alphanumeric number to mask the identity of the product.

The study participants were instructed to consume one tablet of either BSE- 150 mg, BSE 300 mg, or a matching placebo (300 mg microcrystalline cellulose) twice a day after breakfast and dinner for 90 days. All the tablets were of the same size, weight, and color and comparable to each other. Compliance was assessed by recording the number of tablets dispensed to the subject and the numbers returned at each visit in the case record form.

WOMAC, VAS Pain Scale, European Q5D QOL, Lequesne functional Index tests, Six Minute Walk Test, and Physician Global Assessment were administered on the baseline, and days 30, 60, and 90. X-ray of the knee (Anteroposterior view), and biomarkers, were analyzed on baseline and day 90. Safety assessments were carried out on day 0, day 30, and day 90. The participants are allowed to take Celecoxib 200 mg orally a day as a rescue medication if required. Residual efficacy was evaluated 15 days after the end of the study period by asking the participant about his/her perception of pain and recording the VAS score.

The presence of OA was assessed based on the X-ray of the knee joint, AP view on standing as Grade 0-Normal joint with radiological findings in OA; Grade I-Doubtful narrowing of joint space and possible osteophytic lipping; Grade II- Definite osteophytes and possible narrowing of joint space: Grade III-definite narrowing of joint space, with moderate multiple osteophytes, and, possible deformity of bone contour; Grade IV-Marked narrowing of joint space with large osteophytes, definite deformity of bone contour and severe sclerosis (Kohn et al., 2016).

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