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Review of the intended work


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6.0



BRIEF REVIEW OF THE INTENDED WORK :



6.1. INTRODUCTION :

Spontaneous abortion is noninduced embryonic or fetal death or passage of products of conception before the 20th week of pregnancy. Threatened abortion is vaginal bleeding occurring during this time frame and indicating that spontaneous abortion may occur. Diagnosis is by clinical criteria and ultrasonography. Treatment is usually with bed rest for threatened abortion and, if spontaneous abortion has occurred or appears unavoidable, uterine evacuation. Death of the fetus or passage of products of conception (fetus and placenta) before 20 week of pregnancy is considered abortion. Fetal death after 20 week is considered late fetal death and, with delivery, is considered a stillbirth. Passage of a live fetus between 20 and 37 week is considered preterm delivery Abortions may be classified as early or late, spontaneous or induced for therapeutic or elective reasons.



Classification of Abortion:
Type Definition

Early : Abortion before 12 week gestation

Late : Abortion between 12 and 20 week gestation

Spontaneous : Abortion that is not induced

Induced : Termination of pregnancy for medical or elective reasons

Therapeutic : Termination of pregnancy to preserve the woman's life or health, or

because of fetal death or malformations incompatible with life

Threatened : Vaginal bleeding occurring before 20 week gestation without cervical

dilation, which indicates that spontaneous abortion may occur

Inevitable : Vaginal bleeding or rupture of the membranes accompanied by

dilation of the cervix

Incomplete : Expulsion of some products of conception

Complete : Expulsion of all products of conception

Recurrent : Two or more consecutive spontaneous abortions

(habitual)






Missed : Undetected death of embryo or fetus that is not expelled and causes no

bleeding (ie., blighted ovum, anembryonic pregnancy, or fetal demise)

Septic : Serious infection of the uterine contents during or shortly before or

after an abortion

About 20 to 30% of women with confirmed pregnancies bleed during the 1st 20 week of pregnancy; half of these women spontaneously abort. Thus, incidence of spontaneous abortion is about 10 to 15% in confirmed pregnancies. Incidence in all pregnancies is probably higher because some very early abortions are mistaken for a late menstrual period.

In recent decades there is large increase in spontaneous abortion; it is mainly prevalent in young couples. In cities, estrogens such as diethylstilbesterol and other synthetic derivatives are being used as antiabortifacient agents. These are orally active highly synthetic compounds which affect the reproductive development of the female fetus. Hence some of these agents are banned in many countries. The safety of the other drugs is being used is doubtful and needs further investigation. However, a large number of plants are being used in India traditionally to prevent abortion. So far none of these plants are scientifically investigated for the folklore claim.

Nanonut-9TM is a formulation nine highly acclaimed ayurvedic herbs of nutritional and rasayana (antiageing, immunomodulatory, antioxidant and antiglycosylation) value. They are Asparagus racemosus (Shatvari), Ipomoea digitata (Vidari), Trapa bispinosa (Shringatak), Embelica officinalis (Amlaki), Glyccerhiza glabra (Yashti madhu), Sida cardifolia (Bala), Withania somnifera (Ashwagandha), Hemidesmus indicus (Anantmool sariva), Tribulus terrestris (Gokhru). It cleanses blood, improves circulation, reduces blood pressure, provides high quality proteins, vitamins and minerals for increasing fetus weight, regulate harmones and prevent threatened abortion. It is used in pregnancy and lactation for prevention of eclampsia, IUGR (Intra Uterine Growth Restriction), threatened abortion, and used as nutritional supplement. It is found to contain 15 amino acids in both free and hydrolysate form, 9 of them are essential. Studies on prevention of oxidative damage on rat liver cell mitochondriya reveals that nanonut-9 is an excellent antioxidant comparing to vitamin-E1. An HPTLC study revealed the presence of gama









linolenic acid in it1. The formulation is based on the experience of herbal practitioners. However so far, the antibaortifacient activity Nanonut-9 is not proved scientifically. Hence in the present study we are interested in screening the formulation for its antiabortifacient activity in rats.


6.2 NEED FOR THE STUDY :
Miscarriage or spontaneous abortion is the natural or spontaneous end of a pregnancy at a stage where the embryo or fetus is incapable of surviving, generally defined in humans at prior to 20 weeks of gestation. Miscarriage is the most common complication of early pregnancy. The medical term “spontaneous abortion” is used in reference to miscarriages because the medical term “abortion” refers to any terminated pregnancy, deliberately induced or spontaneous, although in common parlance it refers specifically to active termination of pregnancy.

Determining the prevalence of miscarriage is difficult. Many miscarriages happen very early in the pregnancy, before a woman may know she is pregnant. Treatment of women with miscarriage at home means medical statistics on miscarriage miss many cases. Prospective studies using very sensitive early pregnancy tests have found that 25% of pregnancies are miscarried by the sixth week LMP (since the woman's Last Menstrual Period).Clinical miscarriages (those occurring after the sixth week LMP) occur in 8% of pregnancies. The risk of miscarriage decreases sharply after the 10th week LMP, i.e. when the fetal stage begins. The loss rate between 8.5 weeks LMP and birth is about two percent; loss is “virtually complete by the end of the embryonic period."

Although a woman physically recovers from a miscarriage quickly, psychological recovery for parents in general can take a long time. People differ greatly in this regard: some are 'over it' after a few months, others take more than a year. Still others may feel relief or other less negative emotions. For those who do go through a process of grief, it is often as if the baby had been born but died. How short a time the fetus lived in the womb may not matter for the feeling of loss. From the moment pregnancy is discovered, the parents can start to bond with the unborn child. When the child turns out not to be viable, dreams, fantasies and plans for the future are disturbed roughly. Besides the feeling of loss, a lack of understanding by others is often important. People who have not experienced a miscarriage themselves may find it hard to empathize with what has occurred and how upsetting it may be. This may lead to unrealistic expectations of the parents' recovery. The pregnancy and miscarriage are hardly mentioned anymore in conversation, often because the subject is too painful. This can make the woman feel particularly isolated. Interaction with pregnant women and newborn children is often also painful for parents who have experienced miscarriage. Sometimes this makes interaction with friends, acquaintances and family very difficult.

Since there are no safe antiabortifacient drugs available, there is need to find out antiabortifacient agents from plants. A large number of such plants are available in ayurveda, which if validated scientifically helps a lot to the society. So far no antiabortifacient activity has been carried out on any plants. Hence the research work is of prime importance.







6.3. REVIEW OF THE LITERATURE:

1. Asperagous racemosus2:

Family: Liliaceae

Part used: Tuberous roots

Chemical constituents: The main constituents are sarsapogenin, glucose,rhamnose.

Ethnomedical uses: Nutritive, galactogogue, aphrodisiac and antioxytocic activities.

Reported uses: It is reported as hypolipidemic, antioxidant activity3 and possess anabolic properties viz growth promotion.

2. Ipomoea digitata2:

Family: Convulvulaceae

Part used: Dried root

Chemical constituents: The main constituents are resins, sugars, principally starch

Ethnomedical uses: Aphrodisiac, lactogoggue, mucilaginous and moderating menstrual discharge.

Reported uses: It is reported as galactogogues, antihepatotoxic, immunomodulatory activities4 and antioxidant activity5.

3. Trapa bispinosa2:

Family: Onagraceae

Part Used: Fruit

Chemical constitutes: The main constituents are manganese and starch.

Ethnomedical Uses: Nervine tonic, nutritive, general debility and seminal weakness.

Reported uses: It is reported as used in cytotoxic effects6, antioxidant activity7 and treating indigestion especially in aesthetic children.

4. Embelica officinalis2:

Family: Euphorbiaceae

Part Used: Fruit

Chemical constituents: The main constituents are vitamin-C, tannins, minerals and pectin.

Ethnomedical Uses: Rejuvenating and nutritive tonic, improves all kinds of debility.

Reported Uses8-10: It is reported as antioxidant activity, gastro protective and in cardiac

effects.





5. Glycerrhiza glabra2:

Family: Papilionaceae

Part Used: Roots

Chemical constituents: The main constituents are glycyrrhizins, asparagines, sugar, acid resin, phosphoric, sulphuric acid and maleic acids, cadium and magnesium salts.

Ethomedical Uses: Astringent, nervine tonic, relieving pain and discomfort, and uterine complaints.

Reported Uses: It is reported as used in polycystic ovary syndrome11, estrogenic effects12 and anti obesity activity13.

6. Sida cardifolia2:

Family: Malvaceaea

Part used: Roots

Chemical constituents: the main constituents are alkaloids (ephedrine), phytosterols, resin acids, and fatty oils.

Ethomedical Uses: Nervine tonic, haematuria, and cardiac tonic.

Reported Uses: It is reported as analgesic activity, anti- inflammatory, hypoglycaemic activity14 and reduce cardiovascular effects15.

7. Withania somnifera2:

Family: Solanaceae

Part used: Roots

Chemical constituents: The main constituents are alkaloids (withanine), steroidal lactones (withanolides) and 16 beta-acetoxy-17(20)-ene.

Ethomedical Uses: Health restorative to pregnant, rejuvenating drug, and as aphrodisiac.

Reported uses: It is reported as higher sexual performance, antistress, antioxidant, immune modulating16 and rejuvenating properties17.

8. Hemidesmus indicus2:

Family: Asclepidaceae

Part Used: Roots

Chemical constituents: The main constituents are coumarin, hemidesmine, smilasperic acid, enzymes, essential oils and a saponin.

Ethomedical Uses: Nutritional disorders, sexual debility,and all kinds of disease caused


7.

by vitiated blood.

Reported Uses: It is reported as antioxidant activity, antithrombotic activity18, antiplatelet aggregation, anticoagulant activity and hepatoprotective19.

9. Tribulus terrestris2:

Family: Zygophyllaceae

Part used: Dried spiny fruit

Chemical constituents: The main constituents are alkaloids, resins, fat and mineral matter (nitrates).

Ethomedical Uses: To ensure fecundity, impotence, seminal debility and as aphrodisiac.

Reported Uses: It is reported as antihypertensive16, and as aphrodisiac activity17.
6.4. OBJECTIVE OF THE STUDY:

1. Collection of Nanonut-9 formulation.

2. Selection of proven fertile female rats.

3. Mating of rats for pregnancy.

4. Ultrasonography scanning on day 7 of pregnancy.

5. Treatment on day 8 to day 14 of pregnancy.

6. Ultrasonography scanning on day 16 of pregnancy.

7. Determination of number of litters is formed and gross formation.



MATERIALS AND METHODS:

7.1. Collection of formulation: The Nanonut-9 capsules will be collected from phytocastle industry which is present in Bangalore.

7.2. Preparation of suspension: A suspension of formulation will be prepared in distilled water suspended with tween-80.

7.3. Animals: Animals used in the experiment will be colony bred wristar strain female albino rats weighing 150-200 g. All the animals will be maintained under controlled standard husbandry conditions with food and water ad libitum.

7.4. Selection of dose: 100 mg/kg b.w and 200 mg/kg b.w.

7.5. Route of administration: Oral route


8.



7.6. Method: Proven fertile female rats will be selected and 10 will be used for each control and experimental group. Rats having regular estrous cycle alone taken for the studies and mated with proven fertile males in the ratio of 2:1 in the estrous phase of the estrous cycle. The presence of spermatozoa in vaginal smear will be taken as day 1 of pregnancy. On day 7 of pregnancy ultrasonography scanning will be done and the number of implantation sites will be counted. The following treatments will be made on day 8 to day 14 of pregnancy of different groups of rats containing 10 in each group. The animals will be observed for any vaginal bleeding after administration of the extracts and standard.

On day 16 of pregnancy ultrasonography scanning will be carried out and the number of implantation sites in each animal will be noted. If implantation sites were present, the animals will be allowed to grow for full term. The number of litters born were noted at the end of gestation and checked for signs of gross malformation. The increase in the number of implantation sites in the treated group indicates antiabortifacient activity.


EXPERIMENTAL DESIGN:

S.no

Drug

Dose

No.of animals

parameters

1.

Control

………

10

1. Number of

implantation



sites

2. Number of litters



2.

Standard drug (Mifepristone)

20 mg/kg

10

3.

Nanonut-9

100 mg/kg

10

4.

Nanonut-9

200 mg/kg

10

5.

Mifepristone + Nanonut-9

(20+100) mg/kg

10

6.

Mifepristone + Nanonut-9

(20+200) mg/kg

10



9.


REFERENCES:

  1. Nanonut-9TM formulation brochure phytocastle, Byadarhalli, Magadi main road, Bangalore-560 091.

  2. Nadkarni KM, Nandkarni AK. Indian materia medica. Bombay; Popular Prakashan Pvt. Ltd. 1994; Vol 1.

  3. Visavvadiya NP, Narasimhachary RL, Hypolipidemic and antioxidant activities of Asperagous racemosus in hypercholesteremic rats. Ind J Pharmacol 2005; 37: 376-80.

  4. Matin MA, Tewari JP, Kalani DK. Pharmacological investigations of Ipomoea digitata. Indian J Med Sci 1969; 23(9):479-82.

  5. Kim BJ, Kim JH, Kim HP, Heo MY. Biological screening of 100 plant extracts for cosmetic use (II): anti-oxidative activity and free radical scavenging activity. Int J Cosmet Sci. 1997; 19(6):299-307.

  6. Kosuge T, Yokota M, Sugiyama K, Okamoto A, Saito M, Yamamoto T. studies on chinese medicines used for cancer. III. Cytotoxic constituent against Hela cells in the fruit of Trapa bispinosa Roxb 1986; 106: 183-85.

  7. Yadav AS, Bhatnagar D. Free radical scavenging activity, metal chelation antioxidant power of some of the Indian spieces. Biofactors 2007; 31(3-4):219-27.

  8. Scartezzini P, Antognoni F, Ragi MA, Poli F, Sabbioni C. Vitamin C content and antioxidant activity of the fruit and of the ayurvedic preparation of Emblica officinalis. J Ethnopharmacol 2006; 104: 113-18.

  9. Al-Rehaily AJ, Al-Howiriny TA, Al-sohaibani MO, Rafatullah S. Gastroprotective effects of Emblica officinalis on invivo test models in rats. Phytomedicine 2002; 9: 515-22.

  10. Rajak S, Banarjee SK, Sood S. Emblica officinalis causes myocardial adaptation and protect against oxidative stress in ischemic –reperfusion injury in rats. Phytother Res 2004; 18: 54-60.

  11. Armanini D, Castello R, Scaroni C. Treatment of polycystic ovary syndrome with spironolactone plus licorice. Eur J Obstet Gynecol Reprod Biol. 2007; 131: 61-67.









  1. Liu J, Burdette JE, Xu H, Gu C, Van Breemen RB, Bhat KP et.al. Evaluation of estrogenic activity of plant extracts for the potential treatment of menopausal symptoms. J Agric Food Chem 2001; 49(5):2472-9.

  2. Kamisoyama H, Honda K, Tominaga Y, Yokota S, Hasegawa S. Investigation of the anti obesity action of licorice flavanoid oil in diet induced obese rats. Biosci Biotechnol Biochem. 2008; 72(12):3225-31.

  3. Kanth VR, Diwan PV. Analgesic, anti-inflammatory and hypoglycemic activities of Sida cardifolia. Phytother Res 1999; 13: 75-77.

  4. Medeiros IA, Santos MR, Nascimento NM, Duarte JC. Cardiovascular effects of Sida cardifolia leaves extract in rats. Fitoterapia. 2006; 77(1):19-27.

  5. Ziauddin M. Studies on the Immunomodulatory effects of Ashwagandha. J Ethnopharmacol 1996; 50: 69-76.

  6. Jain S, Shukla SD, Sharma K, Bhatnagar M. Neuroprotective effects of Withania somnifera Dunn. In hippocampal sub-regions of female albino rat. Phytother Res 2001; 15: 544-48.

  7. Mary NK, Achuthan CR, Babu BH, Padikkala. In vitro antioxidant and anti thrombotic activity of Hemidesmus indicus. J Ethnopharmacol 2003; 87: 187-91.

  8. Baheti JR, Goyal RK, Shah GB. Hepatoprotective activity of Hemidesmus indicus in rats. Indian J Exp Biol. 2006; 44(5):399-402.

  9. Sharifi AM, Darabi R, Akbarloo N. Study of antihypertensive mechanism of Tribulus terrestris in 2K1C hypertensive rats: role of tissue ACE activity. Life Sci 2003; 73: 2963-71.

  10. Gauthaman K, Adaikhan PG, Prasad RN. Aphrodisiac properities of Tribulus terrestris extract (Protodioscin) in normal and castrated rats. Life Sci 2002; 71: 1385-96.








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