Randomized open label comparative clinical study on the efficacy of combination of Chandana Churna and Shatapushpa Taila Nasya with Tranexamic Acid in Rakta Pradara (DUB)

S Shilpa B; M Sridevi

doi:http://dx.doi.org/10.21760/jaims.7.1.2

Randomized open label comparative clinical study on the efficacy of combination of Chandana Churna and Shatapushpa Taila Nasya with Tranexamic Acid in Rakta Pradara (DUB)

Shilpa B S.^1*, Sridevi M.²

DOI: http://dx.doi.org/10.21760/jaims.7.1.2

^1* S Shilpa B, Post Graduate Scholar, Department of Prasuti Tantra & Stree Roga, Shri Jagadguru Gavisiddeshwara Ayurvedic Medical College, Koppal, Karnataka, India.

² M Sridevi, Professor & HOD, Department of Prasuti Tantra & Stree Roga, Shri Jagadguru Gavisiddeshwara Ayurvedic Medical College, Koppal, Karnataka, India.

Incidence of Rakta Pradara (DUB) is on rise due to life style changes. Rough estimate suggests that 10 to 13% of all gynaecological outpatients are for Rakta Pradara(DUB).[1] Dysfunctional uterine bleeding is a state of abnormal uterine bleeding without any clinically detectable organic, systemic and iatrogenic cause.[2] As per Nidhana of Rakta Pradara the aggravated Vata withholds Rakta vitiated due to various reasons mentioned in Nidana of Rakta Pradara increases its amount reaching Rajovaha Srotas which further increases the rajas, the Srotas involved is Artavavaha Srotas, here Artava Vaha Srotas taken as whole female genital organs along with functional axis i.e., H-P-O axis. Altered H-P-O axis and GNRH regulation causes Rakta Pradara (DUB). So, in this study to treat Rakta Pradara through nearest route Nasya Karma with Shatapushpa Taila is selected along with oral Chandana Choorna along with Madhu and Sharkara.

Keywords: Rakta Pradara, Shatapushpa Taila, Nasya, Chandana Choorna, Artavavaha Srotas

Corresponding Author	How to Cite this Article	To Browse
S Shilpa B, Post Graduate Scholar, Department of Prasuti Tantra & Stree Roga, Shri Jagadguru Gavisiddeshwara Ayurvedic Medical College, Koppal, Karnataka, India. Email:	S Shilpa B, M Sridevi, Randomized open label comparative clinical study on the efficacy of combination of Chandana Churna and Shatapushpa Taila Nasya with Tranexamic Acid in Rakta Pradara (DUB). J Ayu Int Med Sci. 2022;7(1):12-17. Available From https://jaims.in/jaims/article/view/1698

Introduction

Menstruation conception and mother hood are productive aspects of reproduction. The process of reproduction depends on a regular ovulatory menstrual cycle hence women’s menstrual problems acquire a lot of significance.

Acharya Sushruta has considered excessive prolonged or inter menstrual bleeding as Rakta Pradara.^[3]

Length of Rutu Chakra or menstrual cycle is usually 28 days to 30 days. Deviation of 2 or 3 days is quite common. The duration of bleeding is about 5 days and estimated blood loss is 20ml to 80ml. Any deviation in cyclicity and quantity is termed as Rakta Pradara. The normalcy of menstrual cycle depends on hypothalamo pituitary ovarian axis (HPO axis).

Now a day’s females are facing gynecological disorders due to excessive consumptions of junk food sedentary life style, faulty dietary habits and also physical and mental stress because of work load which are considered as etiological factors for Rakta Pradara, so that HPO axis gets impaired.

As per Acharya Charaka Rakta Pitta treatment can be adopted in Rakta Pradara^[4] i.e., Chandana Churna with Sharkara and Madhu along with Tandulodaka Anupana orally is mentioned in the context of Raktapitta Chikitsa. Acharya Kashyapa explains use of Shatapushpa Taila in the form of Nasya in Atyartava in the chapter Shatapuspa Shatavari Kalpa Adhyaya^[5] which is clinically found effective.

Objectives

To compare the effect of Chandana Churna and Shatapushpa Taila Nasya with Tranexamic acid in Rakta Pradara (DUB).

Methodology

Study Design

A randomized open label comparative clinical study.

Duration of Study: 90 days

Assessment Criteria

Data was collected before during and after completion of treatment and subjected for analysis

Subjective Criteria

Bleeding
Pain

Objective criteria: Parameters of assessment

1. Duration of bleeding

1 – 5 days - 0
6 – 9 days - 1
10 – 12 days - 2
>12 days - 3

2. Amount of bleeding

1 – 2 pads per day - 0
3 – 4 pads per day - 1
4 – 5 pads per day - 2
>5 pads per day - 3

3. Interval between two menstrual cycles

26 days -30 days - 0 grade
Less than 26 days - 1 grade
21days - 2 grade
Less than 21 days - 3 grade

Inclusion criteria

Age 15 - 40 years
Excessive bleeding
Inter menstrual bleeding
Prolonged bleeding

Exclusion criteria

Fibroid uterus
Adenomyosis
Thyroid dysfunction
Pelvic inflammatory disease
Endometriosis
Anaemia
Ectopic pregnancy
Abortion
Hypertension
Coronary heart disease
Liver diseases
Malignancy
Diabetes

Duration of treatment - 90 days

Diagnostic criteria

Excessive bleeding
Intermenstrual bleeding
Prolonged bleeding

Laboratory Investigation

Complete blood count
Blood group
Rh factor
Bleeding time clotting time
Liver function test
Random blood sugar
Ultra sonography of pelvis
Thyroid profile (if necessary)
Endometrial biopsy (if necessary)
Pap smear (if necessary)

Estimation

Total 50 patients fulfilling the inclusion criteria were registered for the study.

Total number of patients taken for study - 50
Number of patients taken in Group A - 25
Number of patients taken in Group B - 25

Sample Size

50 Patients having clinical feature of Raktapradara were selected for the study, considering the inclusion and exclusion criteria. Detailed history of the patient, disease and its symptoms were filled according to the proforma prepared for the study incorporating all the relevant points from both Ayurvedic and modern views.

It was Randomized comparative clinical trial; the selected 50 patients were randomly allocated into two groups each having 25 members and named as Group A and Group B.

Group 1

25 women were given Chandana Churna in 5gm bd dose from 5^th day of cycle with Madhu and Sharkara orally with Tandulodaka Anupana till the bleeding stops and then Pratimarsha Nasya with Shatapushpa Taila is started and given till the onset of next cycle, same treatment is continued for next two cycles.

Route of Administration

1. Oral: Chandana Churna 5gm bd from 5^th day till bleeding stops.

2. Nasal: Shatapushpa Taila 2 drops in each nostril from the day of cessation of menses till the onset of next cycle.

Dose

Chandana Churna 5gm

Shatapushpa Taila 2 drops in each nostril Duration: 3 cycles

Group 2: 25 patients with Tranexemic acid for 5 days.

Route of Administration: Oral

Dose: 1 tablet 500mg BD

Duration: 5 days

Both the groups were assessed before and after treatment.

Selection Criteria: The cases were selected strictly as per the pre-set inclusion and exclusion criteria.

Observation

Total of 50 patients were taken for the clinical study and were randomly allocated into group-A and group-B of 25 each.

Results

Overall Response after Treatment

8 patients in group A and 3 patients in group B showed mild response

12 patients in group A and 12 patients in group B showed moderate response

3 patients in group A and 7 patients in group B showed marked response

Therefore, trail group is giving result as good as control group, parameter wise results also showing statistically insignificant difference on 90^th day to 120^th day but on the basis of Mann-Whitney U test ranks group B is better than group A.

Overall Response after Follow-Up: After follow-up i.e., on 120^th day 10 patients in group A and 11 patients in group B showed mild response.

10 patients in group A and 12 patients in group B showed moderate response and none of them showed marked response therefore group A is giving results as good as group B.

Overall Result after Follow-Up: Parameter wise results also showing insignificant difference but on the basis of mean score of all parameters both the groups are equally effective.

Discussion

Discussion on Procedure: Maharishi Kashyapa has mentioned Nasya Karma as one among line of treatment in Atyartava or Raktapradara causing menstrual abnormalities. Menstrual abnormalities caused due to deranged HPO-axis.

Na Hi Vatadrute Vayum Yoni Sampradusyati which tells without role of Vata there is no Stree Roga. In Raktapradara 80% of the cycles are anovulatory, w.s.r to anovulatory factor mainly there is Dusti of Vatadosa. The treatment should be directed to the treatment of Vata and eradication of the cause. In modern science, it is given that the cell produces GNRH originate from the olfactory area and GNRH is a regulator of gonadotropin hormones.

So, considering this relation in mind, it has been tried to see the effect of Nasya in DUB or Raktapradara. So Nasya has role on specifically on Pranavata and Udanavata, there is no other form of medication better than oil for the treatment of Vatadosha. Oil is also said Vatakapha Shamaka. With the help of Taila as media for the action of Nasya on Apana via Pranavata and Udanavata having chain link. So, to treat imbalanced HPO - axis the nearest route is Shiras through Nasamarga. So, Shatapushpa Taila Nasya as Shamana Nasya is selected along with Chandana Churna orally as a Shamana Oushadi.

Discussion on Drug

Chandana Churna: Acharya Charaka explains the use of Chandana Churna with Sharkara along with Tandulodaka Anupana in the context of Rakta Pitta Chikitsa. This Churna has Tiktamadhura Rasa, Ruksha Laghu Guna, Katu Vipaka and Sheeta Virya.^[6] Hence, it is Pitta Shamaka and act as haemostatic in the control of bleeding. Laghu Guna clears all minute channels, Ruksha Guna remove Sroto-Rodha and does the Drava Soshana. Sheeta Virya helps in Rasa Dhatu Utpathi and

reduce Agni Guna in Artava by balancing Pitta. Katu Vipaka helps in Vata Shamana and Kapha Shamana hence Jataragni Mandya and Rasa Dhatu Agni Mandya can be corrected which helps in Utpathi of Rasa Dhatu in healthy state and Madhura Vipaka Sharkara controls Apana Vayu thereby inducing normal bleeding.

Shatapushpa Taila: Acharya Kashyapa has described the effect of Shatapushpa in various gynaecological disorders in separate chapter i.e., Shatapushpa Shatavari Kalpa Adhyaya.^[7] He explains it is Ritupravartini, Yonisukra Vishodini, Putra Prada, Viryakari etc properties. So, it is used in Artava Kshaya, Atyartava, Alpa Artava, Yoni Suskata, Vandya and Shandi.

Shatapushpa consists of mono-terpine such as carvone, limonine and trans-anethole and some flavonoids such as kaemferol and veccin. Kaemferol, trans-anethole and limonine exhibit phyto-estrogenic activity. Phyto-estrogen can be useful in both hyper estrogenic and hypo estrogenic state in the body due to their adoptogenic activity. Thus depending on the target tissue, it may be estrogenic and anti-estrogenic. So, it is useful in any of the above condition including DUB too as highlighted by Maharashi Kashyapa.

Shatapushpa because of its hypo-lipidemic and hypo-cholesterolaemic action helps to maintain BMI and help in the regulation of HPO-axis, hence re-corrects menstrual cycle.

Another mechanism for action of phytoestrogen may be their ability to effect the endogenous production of estrogen. The pituitary gland releases gonadotropins that stimulate estrogens synthesis in the ovaries. This enhances the ovulation and effective in the management of anovulatory cycles in DUB.

Presence of tannin is contributory to overcome the bleeding which may be due to ovulatory cycles in DUB.

Discussion on the basis of result

Within Group-A: The effect of treatment after follow-up 1, 2 & 3 when compared with before treatment within group-A in all the parameters with reduction in mean score is statistically significant. This indicates that Shatapushpa Taila Nasya and Chandana Churna orally helps to eliminate the Srotodusti and thus controls the duration and amount of bleeding in DUB (Rakta-Pradara).

The overall effect of treatment after follow-up in all parameters in group-A was 40% (10) which are rated as moderate response in relieving the disease Rakta-Pradara.

Within Group-B: The effect of treatment after follow-up 1, 2 & 3 when compare to before treatment in group-B in all the parameters with reduction in mean score is statistically significant because of its anti-fibrinolytic activity.

The overall effect after follow-up in all parameters in group-B was 48% (12) which are rated as moderate response in relieving DUB.

Discussion on comparison between the groups after treatment: Among 50 patients 12 patients (48%) shows moderate response in group-A and 12 patients (48%) shows moderate response in group-B. 12% (3) patients from group-A and 7 patients (28%) from group-B shows marked response. This shows that trail drug is equally effective and giving results very near to control drug.

Discussion on comparison between groups after follow-up: Among 50 patients 10 patients (40%) from group-A and 12 patients (48%) from group-B shows moderate response and none of them showed marked response. This indicates that both the groups moderately respond to the treatment, hence both the drugs can be given and are equally effective.

Conclusion

Conclusions are the take outs from the whole work after detailed study of Rakta Pradara and its management. Pradeerana is the excessive expulsion of Raja or menstrual blood so called Pradara and Deerana is excessive expulsion of Asrig (blood), hence, it’s called Asrigdara. 10 to 30% of the reproductive age group women suffer from dysfunctional uterine bleeding. Dysfunctional uterine bleeding is a state of abnormal uterine bleeding without any clinically detectable organic systemic and iatrogenic cause. Menstruation mainly depends upon the Vata i.e., Apana Vata and Vyana Vata. Hypo-thalamo-pituitary-ovarian function has important role in the physiology of menstruation. The endometrium also undergoes a series of cyclical changes with the influence of hormones. Excessive amount of bleeding or prolonged bleeding per vagina with or without associated features, any one of the above are also important symptoms of

Rakta Pradara. Intake of excessive Lavana, Amla, Guru, Ushna, Vidahi, Vishtambi and Virudha Ahara meat of fatty domestic and aquatic animals, Kshara Krushara, Payasa (rice cooked with milk and sweetened) curd, vinegar, Mastu (curd water), wine, exhausting activity and emotional upset etc. are the contributing factors for the incidence of Rakta Pradara to occur. The main line treatment of Rakta Pradara is Rakta Stambana Pitta Kapha Shamana and correction of Vata Dusti. Vata Dosha is responsible for the entire hormonal imbalance or hypothalamo-pituitary-ovarian axis derangements in the body. Chandana Churna with Sharkara and Madhu along with Tandulodaka Anupana acts as a haemostatic factor in the control of bleeding which is also a Pitta Shyamaka Dravya. The nearest route to correct the hypo-thalamo-pituitary ovarian axis derangement is tried in this dissertation work. So, Shatapushpa Thaila Nasya is chosen to treat hypo-thalamopituitary ovarian axis derangement through nasal route, along with oral Chandana Churna with Sharkara Madhu and Tandulodaka Anupana. By Nasya Vata Dosha is regulated and hormonal pathway is corrected. Thus, it is concluded that Shatapushpa as media in the oil for Nasya and Chandana Churna as an oral medicine shows better results in controlling the amount and duration of bleeding and normalizing ovarian dysfunction. No untoward effect is seen with Nasya and oral Churna in any of the patient. The effect of therapy on chief complaints Shatapushpa Taila Nasya and oral Chandana Churna moderate results in both i.e., amount of blood loss and duration of blood loss. Among 50 patients 10 showed mild response (40 %) while 10 (40%) patient showed moderate response and none of them showed marked response in trail group and 11 patient (44%) showed mild response, 12 patient (48%) showed and none of them showed marked response in control group. 5 patient (20%) from trail group and 2 patient (8%) from control group were unchanged. Hence, the results of trail group are nearer to the control group and both the drugs are equally effective.

Reference

Dutta’s text book of gynecology, edited by Hiralal konar, 8^th edition page number 154
Dutta’s text book of gynecology, edited by Hiralal konar, 8^th edition page number 156

Sushruta Samhita of Sushruta with Ayurveda Tatva Sandipika hindi commentary by Kaviraja Ambika Dutta Shastri, Chaukhambha Sanskrit Sansthan Varanasi, Part 1-2, 9th edition 1995. Sha.2/18,19 Page. No. 346
Charaka Samhita with Vidyotini hindi commentary by Pt. Kashinath Shastri & Dr. Gorakhanatha Chaturvedi, Part-1 & 2, published by Chaukhambha Bharti Academy Varanasi, 22nd Edition 1996. Chi. 30/204-209, Page No.868
Kashyapa Samhita of Vriddha Jivaka revised by Vatsya with Sanskrit introduction by Pandit Hemaraja Sharma, Chaukhamba Sanskrit Series, 2002.Klp.5/9-13
Bhisajya Ratnavali of Govind Das ji, edited by bhishag ratna Sri Bramhashankar Mishra, English translation by Kanji lochan translation reviewed by Anand choudary, choukambha Sanskrit sansthan, volume 3, Varanasi, edition reprint 2006, chapter no 66/20, page no 342
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Manuscript Received	Review Round 1	Review Round 2	Review Round 3	Accepted
2022-01-25	2022-01-27	2022-02-03	2022-02-10	2022-02-17
Conflict of Interest	Funding	Ethical Approval	Plagiarism X-checker	Note
Nil	Nil	Yes	18%

Research Article

Chandana Choorna

Journal of Ayurveda and Integrated Medical Sciences

Randomized open label comparative clinical study on the efficacy of combination of Chandana Churna and Shatapushpa Taila Nasya with Tranexamic Acid in Rakta Pradara (DUB)

Shilpa B S.^1*, Sridevi M.²

Introduction

Objectives

Methodology

Observation

Results

Discussion

Conclusion

Reference

Research Article

Chandana Choorna

Journal of Ayurveda and Integrated Medical Sciences

Randomized open label comparative clinical study on the efficacy of combination of Chandana Churna and Shatapushpa Taila Nasya with Tranexamic Acid in Rakta Pradara (DUB)

Shilpa B S.1*, Sridevi M.2

Introduction

Objectives

Methodology

Observation

Results

Discussion

Conclusion

Reference

Shilpa B S.^1*, Sridevi M.²