The research work entitled “Efficacy of Kashmaryadi Ghrita in reducing the incidence of Garbhasrava (abortion) : A randomized controlled clinical trial†was aimed to evaluate and compare the effect of Kashmaryadi Ghrita and micronized progesterone orally in reducing the incidence of Garbhasrava & to explore the etiopathogenesis of Garbhasrava in modern & Ayurvedic parlance. The study was undertaken keeping in view the present lifestyle, a main reason for abortion affecting a mother’s physical as well as emotional state. Moreover, to develop a standard Ayurvedic formulation to reduce the incidence of Garbhasrava, the present study was done. The trial was summarized in 1. Introduction 2. Conceptual study which includes Disease (Ayurvedic review & Modern review) and Drug review with Pharmacognostical & Pharmaceutical Study 3. Clinical Study 4. Discussion 5. Summary & Conclusion.
HYPOTHESIS NULL HYPOTHESIS (H0) Kashmaryadi Ghrita is not as effective as micronized progesterone in reducing the incidence of Garbhasrava (abortion). ALTERNATE HYPOTHESIS(H1) Kashmaryadi Ghrita is equally or more effective than micronized progesterone in reducing the incidence of Garbhasrava (abortion). STUDY DESIGN Study type – Interventional Intervention model – 2 Groups Assignment Sample Size – 100 (50 in each Group) Allocation (Method of randomization) - Computer generated randomization chart Purpose - Prevention Masking - Open label Timing - Prospective End point – Efficacy & Safety Introduction – In this part, a brief description regarding the topic Garbhasrava with abortion in modern terms along with its prevalence, need & importance of the study, history of previous research works done, plan of study with aims & objectives, hypothesis and study design was mentioned in detail. Conceptual Study – Disease Review Ayurvedic Review – In this part, the literature related to the Ayurvedic concept of abortion , Garbhasrava was explained in detail starting from the concept of Garbha in Ayurveda, essential factors mentioned for conception explained in different Ayurvedic texts, development of fetus , Garbhaposhana concept in Ayurveda, Monthwise development of fetus , various Garbhini Lakshana mentioned in Ayurveda after attaining pregnancy in terms of Sadyograhit Garbha and Vyakta Garbha Lakshana. Garbhasrava/ Garbhapata was detailed in terms of Paribhasha, Nidana, Samprapti, Lakshana and Chikitsa. In Ayurveda , the word Garbhasrava and Garbhapata is used for abortion. Though the description of Garbhasrava is mentioned by different Acharyas, still the features of Garbhasrava are seen in various other diseases mentioned in Ayurveda like Yonivyapad, Jataharini, Shukradushti etc. So, all the causes of these diseases were also taken into consideration and treatment of these diseases could also be used according to the cause and described in the disease review. After collecting all the available mentioned literature regarding this, it was seen that the main Doshas responsible for Garbhasrava are Vata and Pitta. Modern Review – It included the monthwise development of fetus according to modern science, description of abortion as its definition, etiology, Pathogenesis, detailed description of types of abortion along with its clinical features, differential diagnosis, investigations, complications & management, Recurrent abortion was explained in terms of etiology, diagnosis and management. At last, Sonography related details or parameters to assess growth and development of embryo or fetus in first trimester and then at 18-22 weeks was mentioned. Drug Review – In this part of the study, description of the Ayurvedic trial formulation drug and modern drug selected and used for the study was mentioned in detail. Ayurvedic formulation details were mentioned with its each ingredient description and related researches. Pharmacognostical study - Authenticity of the raw drugs of Kashmaryadi Ghrita was evaluated through pharmacognostical procedures. Organoleptic characters and powder microscopy of Kashmaryadi Ghrita ingredients was done as per the guidelines of Ayurvedic Pharmacopoeia of India. Pharmaceutical study – The drug was analyzed using different physicochemical parameters and HPTLC profile of the drug was developed. All physicochemical parameters with HPTLC was under basic quality standards. Clinical Study - The study was conducted by registering the patients fulfilling the inclusion criteria i.e. pregnant patients in first trimester (6-10 weeks) with history of spontaneous abortion, history of infertility, elderly primigravida, threatened abortion in present pregnancy into two groups- Group A & Group B. The patients were enrolled on the basis of computer generated randomization chart. 50 patients in Group A and 51 patients in Group B were registered for the study, being a total of 101 patients. In Group A, Kashmaryadi Ghrita was given orally in dose of 12 gms two times a day empty stomach wih a cup of cow milk for 2 months to pregnant women while in Group B, Micronized progesterone 200 mg twice a day with water orally after meals was given for 2 months to pregnant women. In both the groups, normal antenatal care protocol was advised to follow along with the drug. The patient was advised to come at 4 weeks interval and was advised Pathya Apathya with follow up at 18-20 weeks of pregnancy. All the patients were subjected to detailed history taking based on specially designed proforma and screened for Blood Group with Rh factor, HIV, HbsAg, VDRL before enrolment. Hb, TLC, DLC , ESR, Platelet count, PCV, Total RBC Count, BT, CT, FBS, LFT (Total Protein, S. albumin, S. globulin, SGOT, SGPT, Alkaline Phosphatase, S. Bilirubin), RFT (S. Urea, S.Creatinine) , S Cholesterol, Urine examination (Routine & Microscopic) , T4, TSH, S. Progesterone was carried out before & after treatment. T4 & TSH was repeated after treatment only in those patients who have abnormal report before treatment. TORCH test was done in selected patients. Ultrasonography was also done at first visit, at 11-13 weeks of pregnancy and at 18-20 weeks of pregnancy to detect any congenital anomaly. Among 101 patients, 34 patients in Group A and 37 patients in Group B completed the course. 4 patients in Group A and 6 patients in Group B underwent abortion during the course of treatment. 12 patients in Group A and 8 in Group B could not complete the course due to their personal reasons and due to the prevailing corona virus condition at that time. Total 81 patients completed the study. Observations of all registered patients (n=101) were included in the study and results of only those who have completed the study (n=81) were analyzed. The effect of the therapy was assessed on the basis of subjective parameters like continuation of pregnancy, relief in clinical features associated with Garbhasrava i.e. pain in lower abdomen and Bleeding Per vaginum, relief in minor ailments (associated features) of first trimester of pregnancy like Daurbalya, Aruchi, Nausea & Vomiting, Constipation, Pallor, Regurgitation & Heartburn, Palpitation, Shrama, Bhrama, Trishna, Katishoola & objective parameters like change in Serum Progesterone level and various diameters of embryo or fetus observed in Sonography. The observations were subjected to statistical evaluation to get the final results. · Out of total 81 registered patients, 71 patients i.e. 87.7% continued their pregnancy while 10 patients i.e. 12.3% of patients had abortion during course of treatment. In Group A, total 34 patients continued their pregnancy i.e. 89.5% of the patients of Group A while in Group B, 37 patients continued their pregnancy i.e. 86% of the patients of Group B while 4 patients in Group A i.e. 10.5% and 6 patients i.e. 14% in Group B underwent abortion. · Out of total 34 patients who were TORCH positive, 26 patients i.e. 76.5% continued their pregnancy while 7 patients i.e. 20.6% of patients had abortion during course of treatment and 1 patient in Group A dropped out. In Group A, out of total 21 patients, 16 patients i.e. 80% continued their pregnancy and 4 patients i.e. 20% underwent abortion while in Group B, out of total 13 patients, 10 patients continued their pregnancy i.e. 76.9% and 3 patients i.e. 23.1% in Group B underwent abortion. Discussion – In this part, discussion was done on selection of topic, disease, drug, clinical study’s observations and results with effect of therapy. Probable mode of action of drug was also discussed in this part. • The trial drug Kashmaryadi Ghrita possess Garbhasthapaka, Rasayana, Raktapittashamaka and Raktastambhaka properties. • Pregnancy continuation seen in Group A is 89.5% while in Group B it is 86%. • Abortion in Group A is seen in 10.5% of cases while in Group B it was seen in 14%. • In cases of TORCH positive patients, pregnancy was continued in 80% cases in Group A while continuation of pregnancy was seen in 76.9% in Group B and abortion was seen in 20% of cases in Group A while in Group B 23.1% cases result in abortion. • Moreover, on various blood & urine parameters, both Groups didn’t show any difference in results which are different from changes commonly seen during pregnancy. • So, it can be inferred that though statistically no significant results were found in both the groups in various parameters but clinically percentage wise Group A showed better results in pregnancy continuation and abortion than Group B. So, the null hypothesis is rejected and alternate hypothesis is accepted. Kashmaryadi Ghrita is equally effective as micronized progesterone in reducing the incidence of Garbhasrava (abortion).
H |