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ORIGINAL ARTICLE
Year : 2016  |  Volume : 37  |  Issue : 2  |  Page : 98-104  

Dhatakyadi Varti – An effective local treatment for Upapluta Yonivyapad (vulvovaginitis during pregnancy): A standard controlled randomized clinical trial


Department of Streeroga and Prasuti Tantra, Institute for Postgraduate Teaching and Research in Ayurveda, Gujarat Ayurved University, Jamnagar, Gujarat, India

Date of Web Publication7-Nov-2017

Correspondence Address:
Nilofar Mohamad Shafi Shaikh
Department of Streeroga and Prasuti Tantra, Institute of Postgraduate Teaching and Research in Ayurveda, Gujarat Ayurveda University, Jamnagar - 361008, Gujarat
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ayu.AYU_54_15

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   Abstract 


Background: Pregnant women are more prone to vulvovaginitis which is a great challenge for obstetricians today. In Ayurveda, Upapluta Yonivyapad described by Acharya Charaka, Sharangadhara, and both Vagbhata can be compared to vulvovaginitis during pregnancy. Aims: The present study aimed to evaluate efficacy of Dhatakyadi Varti in the management of Upapluta Yonivyapad (vulvovaginitis during pregnancy). Materials and Methods: A total of 80 female patients in the age group of 19–40 years were registered and divided into two groups. In Group A (n = 46), Dhatakyadi Varti was inserted intravaginally, and in Group B (n = 34), Clingen vaginal suppository was inserted intravaginally once at bed time for 14 days. The effect of therapy was assessed on the basis of relief in subjective and objective criteria, i.e., vaginal smear test. Results: In subjective parameters, such as Yoni Srava, Yoni Kandu, Yoni Vedana, Yoni Daha and Yoni Daurgandhya, better result was observed in trial Group A receiving Dhatakyadi Varti. Highly significant relief (P < 0.001) was observed in fungal infection, and significant relief (P = 0.005) was observed in Gram - negative bacterial infection and pus cells in Group A. In Group A, 34.88* patients had complete remission, marked improvement was found in 34.88* cases, and only 2.32* patients remained unchanged, while in Group B, 33.33* patients reported complete remission, marked improvement was found in 10* cases, and 20* patients remained unchanged. Conclusion: It was concluded from the clinical trial that Dhatakyadi Varti is highly effective in reducing subjective and objective variables of Upapluta Yonivyapad and can be introduced as a safe herbal therapy of vaginal discharge during pregnancy.

Keywords: Clingen vaginal suppository, Dhatakyadi Varti, Pregnancy, Upapluta Yonivyapad, vulvo-vaginitis


How to cite this article:
Shafi Shaikh NM, Dei L, Donga S. Dhatakyadi Varti – An effective local treatment for Upapluta Yonivyapad (vulvovaginitis during pregnancy): A standard controlled randomized clinical trial. AYU 2016;37:98-104

How to cite this URL:
Shafi Shaikh NM, Dei L, Donga S. Dhatakyadi Varti – An effective local treatment for Upapluta Yonivyapad (vulvovaginitis during pregnancy): A standard controlled randomized clinical trial. AYU [serial online] 2016 [cited 2017 Nov 18];37:98-104. Available from: http://www.ayujournal.org/text.asp?2016/37/2/98/217792


   Introduction Top


Pregnancy is a beautiful phase in women's life and desire to have a healthy progeny is innate and very intense in every living being. Pregnancy is associated with specific anatomical, physiological, and immunological changes that can predispose to infection and also alter the response to the disease process. Some of the infections may be serious and life-threatening for the mother, while others may seriously jeopardize the fetus or neonate leaving the mother asymptomatic. Fetal infections may develop early in pregnancy to produce obvious stigmata at birth. Alternatively, organisms may colonize and infect the fetus during labor and delivery. Infection is the most clearly recognized and more widely studied and responsible for about 20%–40% of all cases of pre-term birth and other complications such as premature rupture of membranes, chorioamnionitis, and spontaneous abortion.[1] As per Acharya Sushruta, as fruits detach from tree untimely due to the effect of Krimis (parasites), Vata and Abhigata, similarly fetus also gets detached due to the influence of all these factors. Upapluta Yonivyapad has been described by Acharya Charaka,[2] both Vagbhata,[3],[4] and Sharangadhara,[5] but only Acharya Charaka has clearly mentioned that it is a disease of a pregnant woman, and thus, it can be compared to vulvovaginitis during pregnancy. According to Acharya Charaka, when a pregnant woman consumes faulty diet or indulges in mode of life capable of vitiating Kapha and also suppresses desire of vomiting and inspiration, then vitiated Vayu withholding Kapha affects Yoni and produces abnormalities such as yellowish vaginal discharge associated with pricking pain and this condition is known as Upapluta Yonivyapad.[6]Acharya Charaka has mentioned Dhatakyadi Taila[7] for Yoni Pichu, for this disease, but in the present study, the same has been prepared in the Varti form considering that Varti Kalpana is convenient for patients as it can be administered by self without much precaution and supervision.

Hence, the clinical study was carried out with the aim to evaluate and compare the efficacy of Dhatakyadi Varti with Clingen vaginal suppository in the management of Upapluta Yonivyapad(vulvovaginitis).


   Materials and Methods Top


Patients

In the present study, patients were selected from the outpatients Department of Stree Roga and Prasuti Tantra with positive Trichomonas vaginalis/fungal hyphae/pus cells in the vaginal smear or Gram-negative organisms in Gram staining were registered for the trial. A detailed history was taken according to the proforma specially prepared for this purpose.

Drugs

The raw drugs for Dhatakyadi Varti [Table 1] were obtained from Pharmacy of Gujarat Ayurved University and authenticated in the Pharmacognosy Laboratory of IPGT and RA. Varti was prepared in the Department of Rasashashtra and Bhaishajya Kalpana. [Table 2] shows the ingredients of Dhatakyadi Varti.
Table 1: Ingredients of Dhatakyadi Yavakuta

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Table 2: Ingredients for each Dhatakyadi Varti of 3 g

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Method of preparation

Dhatakyadi Yavakuta was taken in a big container, and then eight times distilled water was added and heated till it was reduced up to ¼. Prakshepa Dravya was added into Kwatha and the solution was stirred for 5 min. Then, gelatin powder was added into mixture. Whole solution was melted in water bath and propylparaben sodium salt was added. Heat was constantly supplied and the solution was continuously stirred until a homogeneous mixture was obtained; then, it was poured into suitable chilled molds. After the drug settled, it was kept in refrigerator for 15 min and then it was packed into sterile plastic packets.

Ethical clearance

The study had a due clearance from the Institutional Ethics Committee (Ref. PGT/7-A/Ethics/2013-14/1767, dated 10/09/2013) and CTRI registration was done (CTRI Number: CTRI/2015/05/005747). Before initiation of the study, informed written consent was taken from each patient. Patients were asked to withdraw their name from the study at any time without giving any reason if they wish.

Study design

For this clinical trial, an open-labeled randomized standard control interventional method was adopted.

Inclusion criteria

  1. The pregnant women belonging to age group from 19 to 40 years having clinical features such as Yoni Srava (vaginal discharge), Yoni Kandu (itching vulva), Yoni Daha (burning sensation in vagina), Yoni Vedana (pain in vagina), and Yoni Daurgandhya (foul smell in vagina)
  2. White discharge or inflammation present during Speculum examination
  3. Presence of either of Trichomonas vaginalis, fungal hyphae, and pus cells in the vaginal smear or Gram-negative organisms in Gram staining.


Exclusion criteria

  1. Nonpregnant women
  2. Pregnant women having age below 19 years or above 40 years
  3. Hypersensitivity to drug and inability to confine to the protocol
  4. Women with severe physical illness, any systemic disease such as diabetes mellitus, any organic pathology or hepatic, cardiac, renal disease, or any acute infection
  5. History of sexually transmitted diseases or/and of human immunodeficiency virus (HIV).


Investigations

  1. Routine hematological examination such as complete blood count and urine routine and microscopic examination were carried out before and after the course of treatment
  2. Biochemical test, i.e., fasting blood sugar and serological test such as S. venereal disease research laboratory (VDRL) and S. HIV were carried out in all the patients before starting the course of treatment.
  3. Specific investigations such as vaginal pH, vaginal smear, and Gram staining tests were carried out before and after the course of treatment.


Treatment protocol

In Group A, Dhatakyadi Varti (each of 3 g) was inserted intravaginally once at bed time for 14 days, and in Group B, Clingen vaginal suppository (clotrimazole 100 mg, clindamycin 100 mg) was inserted intravaginally once at bed time for 14 days.

Criteria for assessment

Subjective criteria

  • The improvement in the patient was assessed on the basis of relief in the signs and symptoms of the diseases such as Yoni Srava, Yoni Kandu, Yoni Vedana, Yoni Daha and Yoni Daurgandhya and a special scoring pattern was adopted for this.


Objective criteria

Assessment of the therapy was carried out by comparing the before treatment and after treatment changes of vaginal pH, vaginal smear, and Gram staining test.

Follow up

After completion of course, patients were advised to report every 15 days for 1 month.

Assessment criteria for overall effect of therapy

If < 25% changes were found in sign and symptoms of disease, then it was considered as no change in condition, like wise changes of 26%–50% were considered as mild improvement, changes of 51%–75% were considered as moderate improvement, changes of 76%–99% were considered as marked improvement, and 100% relief was considered as complete remission in disease condition.

Statistical analysis

Wilcoxon signed-rank test for nonparametric paired data, paired t-test for quantitative parametric paired data, and unpaired t-test for quantitative unpaired data were used. The results were interpreted at the level of P> 0.05 as insignificant, P < 0.05 as significant, P < 0.001 as highly significant, and P < 0.0001 as extremely highly significant.

Observations

A total of 80 patients of Upapluta Yonivyapad (Vulvovaginitis during pregnancy) were registered. Among them, 46 patients were registered in Group A and 34 patients were in Group B. A total of 73 patients completed the course of treatment while seven patients left the course of treatment (3 patients from Group A and 4 patients from Group B). In the present study, maximum numbers of patients, i.e., 68.75%, belonged from the age group of 25–30 years. Maximum numbers of patients i.e., 76.25% were Hindu, 87.5% were homemakers, 66.25% patients were from lower middle class, and 73.75% of patients were from the joint family. 82.5% of patients belonged to urban area. 62.5% patients had second-trimester pregnancy. 72.5% patients were vegetarian. In diet, 81.25% of patients were consuming Madhura Rasa while 70% were consuming Katu Rasa. Mandagni and Vishamagni were observed in 33.75% and 31.25% of patients, respectively. 47.5% patients were having habit of Vishamashana and 21.25% patients were having the habit of Adhyashana. 38.75% of patients were addicted to tea while 08.75% of patients were addicted to tobacco. Divaswapa (day sleep) was observed in 75% of patients, 56.25% of patients had the history of intercourse 1–2 times/week and Chhardi Nigrahana (suppression of vomiting) was found in 58.75% of patients. Among the chief complaints, maximum numbers of patients, i.e., 100% patients, had complaint of Yoni Srava (vaginal discharge). Yoni Kandu was found in 58.75% of the patients, Yoni Vedana and Yoni Daha were found in 37.5% and 13.75% of cases, respectively. Pandu Pichchhila Yoni Srava (white mucoid discharge) was present in 71.25% of cases, Dadhivat Yoni Srava (curd like discharge) was present in 25% of cases, and Jaliya Yoni Srava (watery discharge) was present in 3.75% of cases. Among the associated complaints, 51.25% patients had complaint of Katishula (backache), 40% patients had Mutradaha (burning micturition), and 26.25% patients had complaint of Udarashula (abdominal pain). On the basis of per speculum examination, vaginitis was observed in 60% of cases, while vulvitis and cervicitis were observed in 43.75% and 15% of cases, respectively. In vaginal pH test, most of the vaginal samples, i.e., 31.25%, indicated vaginal pH 6.0 (acidic) while 28.75% indicated vaginal pH 7.0 followed by 20%, 10%, 8.75%, and 1.25% of vaginal samples indicated 3.0, 4.0, 5.0, and 8.0 (alkaline) vaginal pH, respectively. In vaginal smear test and gram staining, pus cells were observed in 100% cases, fungal hyphae was found in 35% of cases, and Gram-negative bacteria organism was found in 92.5% of cases. During follow-up, 5 patients in Group A and 12 patients in Group B had complaint of recurrence of vaginitis within 1 month.


   Results Top


In symptom of Yoni Srava, better percentage of relief, i.e., 87.5% was found in Group A compared to control group, i.e., 49.15%, and this value is statistically highly significant (P < 0.001). Yoni Kandu was better relieved, i.e., 91.07% in Group A than in Group B, i.e., 64%. These comparative data were statistically highly significant (P < 0.001). Better percentage of relief, i.e., 87.88%, was found in Group A in relieving Yoni Vedana compared with the Group B, i.e., 50%, which was statistically highly significant (P < 0.001). In relieving Yoni Daha and Yoni Daurgandhya, Group A showed better results, i.e., 84.61% and 90%, respectively, than that of Group B which is 57.14% and 70%, but these findings were not statistically significant (P > 0.05) [Table 3] and [Graph 1].
Table 3: Comparative effect of Group A (n=43) and Group B (n=30) on chief complaints of Upapluta Yonivyapad

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Better percentage of relief was found in Group A in relieving Katishula, Udarashula, and Mutradaha, i.e., 50%, 47.37%, and 94.12%, respectively, when compared with the control group, i.e., 23.08%, 40%, and 72.22%. This value was statistically insignificant (P > 0.05).

One hundred percent relief was found in vulvitis in Group A and in control group, i.e., 62.5%. Vaginitis was better relieved in Group A, i.e., 96%, than in Group B, i.e., 87.5%, [Table 4] and [Graph 2].
Table 4: Comparative effect of Group A (n=43) and Group B (n=30) on gynecological examination of the patients of Upapluta Yonivyapad

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Fungal infection was better relieved in Group A, i.e., 78.12%, than in Group B, i.e., 50%, and the difference of effect between the groups was statistically insignificant (P = 0.187). Better percentage of relief was found in Group B in relieving bacterial infection, i.e., 50%, when compared with the Group A, i.e., 17.33%, and it was statistically insignificant (P = 0.002). Better percentage of relief was found in Group B in relieving pus cells 87.5% when compared with the Group A, i.e., 50%. This value was statistically insignificant (P = 0.515) [Table 5] and [Graph 3].
Table 5: Comparative effect of Group A (n=43) and Group B (n=30) on vaginal smear test of the patients of Upapluta Yonivyapad

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Overall effect of therapy

In the trial group, 15 patients (34.88%) got complete remission and 15 patients (34.88%) had marked improvement. While 8 patients (18.60%) were found with moderate improvement, 4 patients (9.30%) with mild improvement, and 1 patient (2.32%) remained unchanged. In the Clingen vaginal suppository group, 10 patients (33.33%) had complete remission and 3 patients (10%) had marked improvement, while 3 patients (10%) had moderate improvement, 8 patients (26.66%) had mild improvement, and 6 patients (20%) remained unchanged [Graph 4].




   Discussion Top


On the basis of all clinical features and principles of treatment, Upapluta Yonivyapad seems to be nearer to vulvovaginitis during pregnancy. Acharya Charaka has mentioned Dhatakyadi Taila for Yoni Pichu, but in this present study, the same drug has been used in the Varti form. Varti Kalpana is convenient for patients to administer by own, and there is no need of any precaution and supervision. As in modern science, vaginal suppositories are of fixed dose, to resemble that parameter vaginal suppositories were prepared.

Most of the drugs of this Yoga have Kashaya Rasa, Ruksha Guna and Kapha Dosha Shamaka properties. They have been reported as Stambhaka[8],[9],[10],[11],[12],[13],[14],[15] (styptic), Garbhashayashothahara (anti-inflammatory),[9],[10],[12],[15],[16],[17],[18]Kandughna[16],[17],[19] (antipruritic), Twagdoshahara[8],[9],[16] (dermatic), Krimighna[8],[11],[18],[19],[20] (anthelmintic), antibacterial,[9],[11],[18] antifungal,[8],[9],[11],[17] and antimicrobial[9],[16] [Chart 1].



In the present study, maximum numbers of patients were from the age group of 25–30 years. This indicates that this disease is a common problem of active reproductive life.[21] Most of patients were from lower middle class; these people cannot get proper diet and hygienic environment. Hence, the chances of infection are higher in lower strata. Most of patients were of second trimester; this suggests that during second trimester, decreased immunity causes decreased local defense mechanism which is also responsible for growth of microorganism. According to Acharya Charaka, 5th month onward Garbhini becomes emaciated, suffers from loss of strength, and feels excessively exhausted.[22] Most of patients had the history of intercourse 1–2 times/week. It is mentioned in Ayurvedic classics that Atimaithuna (excessive sexual intercourse) is one of the important causative factor for all Yonivyapad and during pregnancy is prohibited by Acharyas.[23],[24]

Results of clinical study suggest that Dhatakyadi Varti is much more effective to treat fungal infection compared to clingen vaginal suppositories. In bacterial infection, control group shows better relief compare to Dhatakyadi Varti trial group. Recurrence rate is also low in Dhatakyadi Varti trial group, and it can definitely become effective herbal formulation to treat vulvovaginitis during pregnancy.


   Conclusion Top


Upapluta Yonivyapad is the disease of the pregnant women which produces untowards outcomes if left untreated. Dhatakyadi Varti not only treats the disease but also normalizes the vaginal flora. It can be concluded that Dhatakyadi Varti is highly effective in reducing subjective and objective variables of Upapluta Yonivyapad (vulvovaginitis during pregnancy).

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
   References Top

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Gupta D. Recent advances. In: Obstetrics and Gynaecology. 8th ed. New Delhi: Jaypee Brother Medical Publishers (P) Ltd.; 2008. p. 46.  Back to cited text no. 1
    
2.
Shastri S Satyanarayana, editor. Charaka Samhita of Agnivesha, Reprint edition. Chikitsa Sthana. Che. 30, Ver. 21-22. Varanasi: Chaukhamba Sanskrit Sansthan; 2003. p. 843.  Back to cited text no. 2
    
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P.V. Sharma, Introducter. Ashtang Hridaya of Vagbhata, Uttartantra. Reprint edition. Che. 33, Ver. 48. Varanasi: Chaukhamba Orientala; 2005. p. 580.  Back to cited text no. 3
    
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P.V. Sharma, Introducter. Ashtang Hridaya of Vagbhata, Uttartantra. Reprint edition. Che. 33, Ver. 49. Varanasi: Chaukhamba Orientala; 2005. p. 580.  Back to cited text no. 4
    
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Tripathi B, editor. Sharangdhara Samhita of Sharangdhara, Reprint edition. Che. 7, Ver. 17. Varanasi: Chaukhamba Sanskrit Sansthan; 2005. p. 197.  Back to cited text no. 5
    
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Ibidem. (2) Charaka Samhita. Ch. Chi. 30/21-22. p. 843.  Back to cited text no. 6
    
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Shastri S Satyanarayana, editor. Charaka Samhita of Agnivesha, Reprint edition. Chikitsa Sthana. Che. 30, Ver. 21-22. Varanasi: Chaukhamba Sanskrit Sansthan; 2003. p. 852.  Back to cited text no. 7
    
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Database on Medicinal Plants Used in Ayurveda & Siddha. Reprint edition. Vol. 3. Central Council for Research in Ayurveda & Siddha, Department of AYUSH, Ministry of Health & Family Welfare, GOI; 2005. p. 206.  Back to cited text no. 8
    
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Database on Medicinal Plants Used in Ayurveda & Siddha. Reprint edition. Vol. 3. Central Council for Research in Ayurveda & Siddha, Department of AYUSH, Ministry of Health & Family Welfare, GOI; 2005. p. 11.  Back to cited text no. 9
    
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Database on Medicinal Plants Used in Ayurveda & Siddha. Reprint edition. Vol. 5. Central Council for Research in Ayurveda & Siddha, Department of AYUSH, Ministry of Health & Family Welfare, GOI; 2005. p. 164.  Back to cited text no. 10
    
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Database on Medicinal Plants Used in Ayurveda and Siddha. Reprint edition. Vol. 3. Central Council for Research in Ayurveda and Siddha, Department of AYUSH, Ministry of Health and Family Welfare, GOI; 2005. p. 314.  Back to cited text no. 11
    
12.
Himsagara P, Murty C. Rasasashtra, The Mercurial System year 2008, 3rd edition. Varanasi: Chaukhamba Sanskrit Series Offices, 2008; p. 258.  Back to cited text no. 12
    
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The Wealth of India, a Dictionary of Indian Raw Materials and Industrial Products. Revised Edition. New Delhi: Council of Scientific & Industrial Research; 2007. p. 70.  Back to cited text no. 13
    
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Ibidem. (8) Database on Medicinal Plants. Vol. 3. p. 537.  Back to cited text no. 14
    
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The British Pharmaceutical Codex. Direction of the Council of the Pharmaceutical Society of Great Britain. Second edition. Landon. The Pharmaceutical Press; 1934. p. 477.  Back to cited text no. 15
    
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Ibidem. (8) Database on Medicinal Plants. Vol. 3. p. 561.  Back to cited text no. 16
    
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Database on Medicinal Plants Used in Ayurveda & Siddha. Reprint edition. Vol. 5. Central Council for Research in Ayurveda & Siddha, Department of AYUSH, Ministry of Health & Family Welfare, GOI; 2005. p. 177.  Back to cited text no. 17
    
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Database on Medicinal Plants Used in Ayurveda & Siddha. Reprint edition. Vol. 8. Central Council for Research in Ayurveda & Siddha, Department of AYUSH, Ministry of Health & Family Welfare, GOI; 2005. p. 207.  Back to cited text no. 19
    
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21.
Pandubidri VG, Shirish N. Disease of the Vagina in Howkins and Bourne Shaw's Textbook of Gynaecology. 13th ed. Noida: Printed Godsons Papers Ltd.; 2005. p. 125-27.  Back to cited text no. 21
    
22.
Shastri S Satyanarayana, editor. Charaka Samhita of Agnivesha, Reprint edition. Purvardha, Sharira Sthana. Che. 4, Ver. 21-22,23. Varanasi: Chaukhamba Sanskrit Sansthan; 2003. p. 875-876.  Back to cited text no. 22
    
23.
Shastri S Satyanarayana, editor. Charaka Samhita of Agnivesha, Reprint edition. Purvardha, Sutra Sthana. Che. 25, Ver. 40. Varanasi: Chaukhamba Sanskrit Sansthan; 2003. p. 469.  Back to cited text no. 23
    
24.
Shastri AD, editor. Sushruta, Sushruta Samhita, Reprint edition. Sharira Sthana. Ch. 3, Ver. 16. Chaukhamba Sanskrit Sansthana; 2013. p. 31.  Back to cited text no. 24
    



 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5]



 

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