कोरोनिल – दावे और सच्चाई

आज 23 जून 2020, योग ग्रुरु बाबा रामदेव और आचार्य बालकृष्ण ने कोविड-19 (कोरोना वायरस) के इलाज के लिए दिव्य कोरोनिल टेबलेट और किट लौंच की जिसमे कोरोनिल टेबलेट के आलावा श्वासारि वटी और अणु तैल भी है। इनका दावा है की यह कोरोना वायरस डिसीज को 100 फिसदी ठीक कर सकता है। इनके मुताबिक इन्होने इसका क्लीनिकल ट्रायल कर इसके प्रमाण (एवीडेंस) भी जुटाए है। चलिए इसके बारे मे जानते है:

 बाबा रामदेव और आचार्य बालकृष्ण का दावा है की इन्होने National Institute of Medical Science (NIMS), Jaipur और पातंज़लि रिसर्च इंस्टीट्युट (PRI) ने मिलकर कोरोना की दवा खोज ली है और इसका क्लीनीक्ल ट्रायल भी कर लिया है जहां 69% कोरोना मरीजो मे 3 दिन मे और 100% कोरोना मरीजो मे 7 दिन मे ही दवा के असर से कोरोना रिपोर्ट नेगेटीव आई। लॉंच के समय इनके साथ NIMS के डायरेक्टर डॉ बलवीर सिंह तोमर, NIMS के मेडीसिन विभाग के प्रोफेसर डॉ गणपत देवपुरा, असिस्टेंट प्रोफेसर डॉ अभिशेक शर्मा, PRI के डॉ अनुराग वार्ष्णेय भी मौजूद थे। इन सब के अनुसार दवा का ट्रायल NIMS के मेडिकल कॉलेज हॉस्पिटल मे किया गया। इसमे आयुर्वेद के वैद्य दीपक भण्डारी भी शामिल रहे।

बाबा रामदेव के अनुसार पहले दवा को दिल्ली, अहमदाबाद और भी कई शहरों मे करीब 280 मरीजों को दवा देकर क्लीनिकल केस स्टडीज की गई। (क्लीनिकल केस स्टडी मे किसी एक मरीज हो दवा देकर उस पर उसका दवा लेने से पहले और लेने के बाद आए परिवर्तन का अध्ययन किया जाता है, इसकी बहुत ज्यादा वैज्ञानिक प्रमाणिकता नही मानी जाती पर इशारा भर ज़रुर समझा जा सकता है जिसके आधार पर रिसर्च स्टडीज की जा सकती है)। इनके अनुसार सभी 280 कोरोना मरीजों मे सकरात्मक परिणाम मिले, 100% रिकवरी के साथ साथ, कोई मृत्यु नही देखी गई, symptomatic and systemic improvement (लाक्षणिक और शारीऐक सुधार) देखे गए साथ ही यह भी पाया गया की यह कोरोना से होने वाले उपद्रव (complications) को भी कंट्रोल करता है।

इसके बाद इसकी सही और वौज्ञानिक ढंग से अध्य्यन करने के लिए control clinical study प्लान की गई, जिसके लिए PRI और NIMS  साथ मे आए। 100 लोगों पर यह स्टडी की गई, जिसमे से 95 ने यह ट्रायल पूरा किया। जिन कोरोना मरीजों को यह दवा दी गई, उनमे से 69% मे 3 दिन मे स्वास्थय मे सुधार और कोरोना रिपोर्ट नेगेटिव पाई गई, वही सभी (100%) मरीज 7 दिनो मे ही ठीक हो गये और उनका कोरोना टेस्ट नेगेटिव मिला; जिन मरीजो को प्लेसीबो (एसा पदार्थ जिसका कोई चिकित्सकीय प्रभाव ना हो) दिया गया उनमे 7 दिन मे 65% मरीज ही रिकवर हो पाए। इस ट्रायल मे कोई भी मृत्यु नही हुई। इनका कहना है की Drug discovery के सभी सिद्धांत पालन किए गये।

ट्रायल के दौरान मरीजों को अश्वगन्धा, गिलोय और तुलसी एक्स्ट्रेट, श्वासारि वटी और नाक मे डालने के लिए अणु तल दिया गया। रामदेव के अनुसार कोरोनिल और इसके घटक (अश्वगन्धा, तुलसी और गिलोय) immunity booster होने के साथ साथ, मधुमेह (डायबिटीज), रक्त चाप (Hypertension- high  BP), ज्यादा बढी heart beats, nervine disease मे भी कारगर है। (घटकों के बारे मे ऐसा आयुर्वेद के ग्रंथ भी बोलते है और बहुत सारे रिसर्च पेपर भी प्रकाशित है, और हमारा भी ऐसा ही मानना है)। श्वासारि वटी श्वसन तंत्र मे alveoli (lungs की सबसे छोटी ईकाई) पर काम करता है, श्वसन तंत्र को ठीक करता है, सर्दी, ज़ुकाम पर काम करता है और ऐसा सिद्ध करने वाले रिसर्च पेपर भी प्रकाशित हो चुके है। अणु तैल भी शवसन तंत्र पर काम करता है और कोरोना जैसी बिमारियों से इसे बचाता है।

NIMS से डॉ तोमर और डॉ देवपुरा के अनुसार सभी पैरामीटर्स को पूरा करते हुए इस ट्रायल को पूरा किया गया। यह एक Double-blind placebo-controlled clinical trial था। जिसे एथीएकल कमेटी से पास करवाने के बाद Clinical Trials Registry- India (CTRI) मे registration करने के बाद टायल शुरु किया गया। जिसमे 15-65 साल तक की उम्र के 100 कोरोना मरीजों को लिया गया, 90 ने ट्रायल पूरा किया, जिसमे से 45 को अश्वगन्धा, गिलोय एक्स्ट्रेट, तुलसी एक्स्ट्रेट, श्वासरी वटी और अणु तैल नाक मे डालने के लिए दिया गया, वही बाकी 45 को placebo दिया गया। पहले ग्रूप मे 3 दिन मे 69% और 7 दिन मे 100% रिकवरी रेट मिला वहीं placebo ग्रूप मे 3 दिन मे 52% और 7 दिन मे 65% रिकवरी रेट मिला। statistical analysis (वैज्ञानिक सांख्यिकी विश्लेषण) मे p value 0.033 प्राप्त हुई, जो इसे प्रभावी सिद्ध करती है। ट्रायल के पहले और बाद मे कोरोना जांच के लिए RT PCR test और इसके अलावा oxygen saturation, CRP ( Creactive protein) और interlukin 6 की भी जांच की गई, जिनमे दवा देने के बाद प्रभावी सुधार देखा गया। इसके अलावा सभी मरीजों मे blood chemistry and other routine test भी किए गये। इसमे यह भी देखा गया के अधिकांश मरीज पुरुष थे, आयु के अनुसार ज्यादातर मरीज 31-50 वर्ष आयु के थे। उन मरीजों को अध्ययन से बाहर रखा गया जिनका oxygen saturation 90% से कम था, life expectancy कम भी, या जो acute respiratory disease से जूझ रहे थे।

[CTRI कि वेबसाइट पर ढुंढने पर हमे यह ट्रायल रजिस्टर्ड मिला। इसका CTRI/2020/05/025273 है और यह 20 मई 2020 को रजिस्टर किया गया है। इसका पब्लिक टाईटल Impact of effect of Ayurvedic treatment on novel Corona virus disease और वैज्ञानिक टाईटल Impact of Indian traditional Ayurvedic treatment regime for nCoV-2 (COVID-19) है। इस प्रोजेक्ट के मुख्य जांचकर्ता/अंवेषक डॉ गणपत देवपुरा, स्पॉंसर Patanjali Research Institute Governed by Patanjali Reserach Foundation Trust, Haridwar, Uttrakhand है। इस ट्रायल मे 15-80 वर्ष उम्र के 120 मरीज लेने का प्रोजेक्शन लिया गया है, जो की Respiratory failure जूझ रहे हो, जिनमे COVID-19 test positive हो, जिनमे लक्षण प्रकट ना हो (Asymptomatic patients), कम हो (Mildly symptomatic patients), या मध्यम हो (Moderately symptomatic patients) , जो ट्रायल मे भाग लेने को तैयार हो, गम्भीर और तीव्र लक्षणो वाले मरीजों (Severely symptomatic patients (SaO2 <90%)) को इस ट्रायल से बाहर रखा गया। ट्रायल के 3, 7 और 14 वें दिन नाक या गले से (nasopharyngeal swab)  से सैम्पल लेकर RT PCR test से वायरस की टेस्टिंग करने की बात कही है, इसके साथ ही इस समयावधि मे लक्षणो मे आए परिवर्तन, C-reactive protein, ESR & IL-6 मे आई कमी, heamatological parameters मे हुए परिवर्तन और सुधार को भी आकलन किया जान है। शामिल हुए मरीजों क follow up (दुबारा देखना) भी 14वे और 30वे दिन किया जाएगा। इस ट्रायल मे पहला मरीज 29 मई 2020 को रजिस्टर किया गया और इसके 25वें दिन तक ट्रायल पूरा कर उसका विश्लेषण कर लॉंच कर देना एक असाधारण सी बात है, अगर रजिस्टर्ड ट्रायल को देखे तो किसी भी मरीज का follow up पूरा नही हुआ है। यह स्टडी Interventional Randomized parallel group placebo controlled, Single Centric trial है। इस रजिस्ट्रेशन प्रक्रिया मे दावा है की इनकेद्वारा 100 से मेडिसिनल प्लांट के 1000 के लगभग phytochemicals को screen किया गया और उसकी बाद अश्वगन्धा, तुलसी, गिलोय का चयन किया। जिस ग्रूप मे आयुर्वेदिक intervention दिया गया, उसमे मरीज को सुबह नाश्ते से 1 घण्टे पहले अणु तैल की 4-4 बून्दे नाक के दोनो छेदों (Nostrils ) मे डाले गए, इसके 30 मिनट बाद श्वासारि रस 2 ग्राम गुनगुने पानी के साथ और नाश्ते के 30 मिनट बाद गिलोय एक्स्ट्रेट की 2 टेबलेट (1 टेबलेट- 500 mg), 1 टेबलेट अश्वगन्धा (500 mg) और 1 टेबलेट तुलसी एक्स्ट्रेट (500 mg) की गुनगुने पानी के साथ दी गई। इसी तरह रात के भोजन से 30 मिनट पहले श्वासारि रस 2 ग्राम गुनगुने पानी के साथ और खाने 30 मिनट बाद गिलोय एक्स्ट्रेट की 2 टेबलेट (1 टेबलेट- 500 mg), 1 टेबलेट अश्वगन्धा (500 mg) और 1 टेबलेट तुलसी एक्स्ट्रेट (500 mg) की गुनगुने पानी के साथ दी गई। दूसरे ग्रूप मे placebo दिया गया। हालांकि आज के समय मे मानव हित को ध्यान मे रखते हुए placebo control trail की अनुमति मिलना संशयात्मक है।]

PRI के डॉ अनुराग वार्ष्णेय के अनुसार वे इस कोरोना पर दिसम्बर 2019 से काम कर रहे है, जब चाईना मे कोरोना के मरीज मिलना शुरु हुए थे। (हालांकि ये थोडा अजीब लगता है क्युंकि चाईना ने 31 दिसम्बर 2019 को विश्व स्वास्थ्य संगठन (WHO) को सूचित किया के उनके देश मे न्युमोनिया जैसी एक बिमारी फैल रही है और 41 लोग इससे संक्रमित हो चुके है, तो दिसम्बर तक तो चाईना से बाहर की दुनिया मे इसकी जानकारी बहुत ही सीमित थी)। उन्होने लगभग 100 मेडिसिनल प्लांटस और 150 phytochemicals (biologically active compounds found in plants. पौधों मे पाये जाने वाले रसायन जो की जैविक शरीर पर क्रियाकारी हो) को स्क्रीन और अध्ययन किया। इसमे उन्हे अश्वगन्धा (Withania somnifera)  मे Withanone, गिलोय (Tinospora cordifolia) मे Tinocordiside और तुलसी (Ocimum sanctum) मे Scutellarein प्रभावी मिले।

[अध्ययन के अनुसार Withanone वाइरस को host यानि इंसानि कोशिका मे घुसने से रोकता है, कोरोना वाइरस host cell ACE2 अपने spike protein Receptor Binding Domain (RBD) के द्वारा जुडता है और AEC2-RBD complex बनाता है। Withanone इनको घटाता है और बनने से भी रोकता है। (Agarwal, R., Diwanay, S., Patki, P., & Patwardhan, B. (1999). Studies on immunomodulatory activity of Withania somnifera (Ashwagandha) extracts in experimental immune inflammation. Journal of Ethnopharmacology, 67(1), 27-35.)

गिलोय मे मिलने वाला Tinocordiside भी AEC2-RBD complex से जुडकर संक्रमण को रोकने मे प्रभावी है। गिलोय प्रतिरक्षा तंत्र को भी मजबूत करता है।

तुलसी मे मिलने वाला Scutellarein, नाम क एक  natural flavone कोरोना वाइरस के RDRP एंजाइम (RNA Dependent RNA Polymerase) की क्रिया को रोकने मे प्रभावी पाया गया है। यह एंजाइम ही वाइरस की संख्या मे तेजी से वृद्दि होने के लिए जिम्मेदार है।]

 डॉ वार्ष्णेय के अनुसार वे इस दवा पर और प्रभावी प्रमाण जुटाने मे लगे हुए है। इसका एक्सपेरीमेंटल मोडल (एनीमल्स) पर अध्य्यन चल रहा है। इसके अलावा in vitro bio chemical assay (enzymes या cell line पर होने वाला अध्ययन, जो इसकी कोशिका या enzyme पर दवा की binding और activity को और भी बेहतर समझा सकेगा) पर  भी कामकर कर रहे है। इन्होने दावा किया कि PRI दो अंतर्राष्ट्रीय संस्थाओ, एक जर्मनी और दूसरी अमेरिका से, के साथ मिललर इस पर काम कर रहे है। भारत मे इसका एनीमल ट्रायल ज़ेब्रा फिश पर और सिंगापुर मे चूहों (Mice & rats) पर किया जाएगा।

आचार्य बालकृष्ण के अनुसार वे इसका ट्रायल मध्य प्रदेश मे भी करना चाहते थे पर वहां राजनीतिक उठापठक के कारण उन्हे इसकी अनुमति नही मिल सकी। उनके अनुसार वे इस दवा की पूरी किट (दिव्य कोरोना किट), जिसमे कोरोनिल टेबलेट, श्वासारि वटी और अणु तैल है 545 रुपये मे उपलब्ध कर्वा देंगें। इसके लिए वे एक ओनलाईन स्टोर शुरु कर रहे है, जहां से आप इसे ओर्डर कर 2 घण्टे मे अपने घर पर मंगवा सकेंगें, इसके अलावा यह सभी पातंज़लि स्टोर पर भी उपलब्ध रहेगी।

श्वासारि वटी respiratory disease (allergic asthma) के एनीमल मॉडल मे dexamethasone से ज्यादाप्रभावी पाई गई, ऐसा बालकृष्ण ने बताया। [यह अधिक मात्रा मे होने वाले mucus production को कम करता है, airway remodeling और फेफड़ॉ के सूजन मे pro-inflammatory cytokines pro-inflammatory cytokines को घटाकर सूजन कम करने मे सहायता करता है। ऐस अध्ययन मे पाया गया है।] आचार्य बालकृष्ण ने कहा की आयुर्वेदिक दवा का क्लीनिकल ट्रायल करना बहुत कठिन है, आयुर्वेद की किसी दबा का क्लीनिकल ट्रायल कभी हुआ ही नही। [यह एक गलत तर्क है, आयुर्वेद की बहुत सी दवाओ के अनेको क्लीनिकल ट्रायल हो चुके है। कोरोना वाइरस डिसीज पर भी जयपुर के राष्ट्रीय आयुर्वेद संस्थान मे भी क्लीनिकल ट्रायल चल रहा है।] उन्होने दावा किया की कोरोना वाईरस पर काम करने वाली प्रथम प्रामाणिक आयुर्वेदिक दवा है। इन्होने दावा किया है की दवा का चिकित्सकीय और बचाव दोनों मे प्रभावी है।

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हालांकि दवा पर रिसर्च पेपर प्रकाशित होने पर इसके बारे मे और जानकारी सामनी आ सकेगी। 23 जून को आयुष मंत्रालय ने एक लिखित बयान जारी कर पातंज़लि आयुर्वेद प्रईवेट लिमिटेड द्वारा लांच की गई मेडिसिन के बारे मे जानकारी नही होने की बात कही है, हालांकि दवा बनाने की अनुमति आयुष की ही स्टेट लाइसेंसिग अथोरिटी ने हि दी है, और NIMS & PRI ने वह पत्र भी सर्वजनिक कर दिया जो आयुष की रिसर्च देने वाले विभाग Central Council for Research in Ayurveda Sciences को इसकी जानकारी देने के लिए 2 जून लो किखा गया था। मंत्रालय ने इसे The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 का उल्लंघन माना है। इन्होने संस्था को ट्रायल से जूडी सभी जानकारी पूरे विस्तार के साथ पेश करने को कहा है। 23 जून को शाम तक ही PRI and NIMS ने मंत्रालय को जबाव और सम्बन्धित जानकारी उपलब्ध करावा दी है, यह जवाब सोषल मीडिया पर वायरल भी हो रहा है।

हां, यदि भारत सरकार इस दवा को कोरोना के लिए मंजूर करती है तो यह भारत मे कोरोना के लिए इस्तेमाल होने वाले चौथी और आयुर्वेद की पहली दवा होगी। इससे पहले Cipremi, covifor और fabiflu को इस्तेमाल करने की मंजूरी मिल चुकी है। Cipremi और covifor एंटीवाइरल ड्रग Ramdesivir के जेनेरिक वर्जन है. वहीं fabiflu इंफ्लुएंजा की दवा favipiravir का जेनेरिक वर्जन है, ये तीनो ही modern allopathic medicine है। हालांकि इसकी प्रमाणिकता के लिए आगे और भी रिसर्च वर्क जैसे metacentric trial करने की जरुरत तो हौ और जैसा PRI ने बताया की वे काफी सारे रिसर्च कर भी रहे है और आने वाले समय मे वे इसे प्रकाशित भी करेंगें और क्रिटिकल मरीज जिनमे की गम्भीर लक्षण (sever patients) है, उन पर भी ट्रायल करेंगे। अभी तक हो प्रमाण रखे गये है उससे ये दवा तो प्रभावी लगती है, यदि आयुर्वेदिक सिद्धांतों और published research work के अनुसार भी आकलन करें तो भी प्रभावित लगती है, पातंज़लि ने भी इससे सम्बन्धित एक Document  भी जारी किया है। ऐसे वैश्विक महामारी के समय मे आयुर्वेद और अन्य पारम्परिक मेडिसिन के लिए अवसर भी है, तो इस मंत्रालय इस पर पूरी नज़र और जानकारी रख कर इसे प्रोत्साहित करे तो बेहतर परिणाम आ सकते है। 

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