Management of dermatological manifestation of PCOS by Pathadi and Kanchnaradi kwatha along with Arogyavardhini vati.

Dr. Poonam Choudhary^1*, Dr. Balkrishan Sevatkar², Dr. Sushila Sharma³, Dr. Pawan K. Godatwar²

¹Lecturer, Dept of Prasuti and Stri Roga, NIA, Jaipur, Rajasthan

²Associate Professor, Dept of Roga Nidan and Vikriti Vigyan NIA Jaipur, Rajasthan

³Professor, Dept of Prasuti and Stri Roga, NIA, Jaipur, Rajasthan

*Corresponding Author E-mail: poonam.18veena@gmail.com

ABSTRACT:

Background: Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders in women, affecting 5–10% of reproductive-aged women. The dermatologic manifestations of hyperandrogenism, chiefly hirsutism, acne vulgaris, androgenic alopecia, and acanthosis nigricans, are among the cardinal manifestations of PCOS. Aim: To evaluate the comparative efficacy of the Pathadi Kwatha and Arogyavardhini vati and Kanchnaradi kwatha and Arogyavardhini vati in the management of various cutaneous manifestations in patients with PCOS. Settings and Design: The study was conducted in outpatient and inpatient unit of department of Prasuti tantra and Stree roga of National Institute of Ayurveda, Jaipur. Materials and Methods: The present study included 110 women of 18-40 years diagnosed to have PCOS according to Rotterdem revised criteria 2003. Hormonal analysis as well as radiological assessment was done in all the cases. out of 110 patients 50 patients each were divided in two groups (excluding drop outs) named Group A and Group B. Group A received Pathadi Kwatha and Arogyavardhini vati and Group B received Kanchnaradi kwatha and Arogyavardhini vati Results: In our study, Acne was found in 44% cases, Hirsutism in 84% cases, Alopecia, and Acanthosis nigri cans were present in 51%, and 34% patients respectively. In acne and hirsutism highly significant improvement was observed in both groups, and statistically insignificant result in Alopecia and acanthosis nigricans but percentage of relief is higher in Group A as compare to Group B. Conclusion: The trial drugs Pathadi kwatha and Arogyavardhini vati and Kanchanaradi kwatha and Arogyavardhini vati are equally effective in reducing Dermatologic manifestations of PCOS (Dhatvagnimandya Janya Beejagranthi Vikara).

KEYWORDS: PCOS, hyperandrogenism, Dhatvagnimandya, Arogyavardhini vati.

INTRODUCTION:

Polycystic ovary syndrome (PCOS) (Stein–Leventhal syndrome) is a common hyperandrogenic disorder in women of the childbearing age group. It is a multisystem metabolic disorder, which has a major impact on the quality of life as well as fertility^1,2. If the incidence of polycystic ovarian syndrome is 4% to 22% of women overall and 50% of women seen at infertility clincs^3,4. The World Health Organization estimates that there are one out of forty newly reported cases of PCOS worldwide⁵.

The problems arising due to PCOS (for e.g. - obesity, irregular menstruation, oily skin, acne, seborrhea, hirsutism, alopecia, infertility etc.) can dampen the women's life physically and mentally. So it is important to pay attention and take proper measures against this disease.

In ayurvedic classics it can be described under Ashtoartavadushti, Nastartava, Pushpaghni Jataharini, Granthi. But features of metabolic dysfunction and polycystic ovarian morphology are not evident from any description. So, it may be under stood on the basis of Dosha dushti, involvement of Dushya, Srotas, Ama, Agni, Adhistana and Vyadhi Lakshana. As it seems that whole metabolic process is disturbed in PCOS which is considered as dhatwagni vikar in ayurveda and no any diseases in classics indicate whole specturum of PCOS. So, we can say it “Dhatwagni mandya janya beejagranthi vikar.” Therefore this study has been designed to analyse and evaluate the efficacy of Kanchanaradi kwatha and Pathadi kwatha along with Arogya vardhini vati in dermatological manifestation of PCOS.

Aims and Objectives:

To evaluate the efficacy of trial drugs and compare its effect on dermatological features of PCOS.

MATERIALS AND METHODS:

Study Design:

Single blind randomized Comparative Clinical Trial.

Trial Drug details:

Reference:

Pathadi Kwatha⁶, Kanchanaradi kwatha⁷ and Arogyavardhini vati⁷ Pharmacognostical, analytical study of drug has been carried out for this research work.

Contents of Pathadi Kwatha:

Table1: Contents of Pathadi Kwatha:

S.No	Drug	Latin name	Family	Part used	Ratio
1.	Patha	Cyclea peltata	Menispermacea	Root	1 part
2.	Shunthi	Zingiber officinale	Zingiberaceae	Rhizome	1 part
3.	Maricha	Piper nigrum Linn.	Piperaceae	Fruit
4.	Pippali	Piper longum Linn	Piperaceae	Fruit
5.	Kutaja	Holarrhena antidysenterica	Apocynace	Bark	1 part

Table 2: Contents of Kanchanaradi Kwatha:

S.No	Drug	Latin name	Family	Part	Ratio
1.	Kanchanara	Bauhinia variegata Linn.	Leguminosae	Bark	5part
2.	Amalaki	Emblica officinalis Linn.	Euphorbiaceae	Fruit	1/2 part
3.	Haritaki	Terminalia chebula Retz.	Combretaceae	Fruit	1/2 part
4.	Bibhitaki	Terminalia bellirica Roxb.	Combretaceae	Fruit	1/2 part
5.	Shunthi	Zingiber officinale	Zingiberaceae	Rhizome	1 part
6	Maricha	Piper nigrum Linn.	Piperaceae	Fruit	1part
7.	Pippali	Piper longum Linn	Piperaceae	Fruit	1part
8.	Varun	Crataeva nurvala	Capparidace	Bark	1/4 part
9.	Ela	Elettaria cardamomum	Zingiberaceae	Fruit	1/8 part
10.	Dalchini	Cinnamomumm zeylanicum	Lauraceae	Bark	1/8 part
11.	Tejpatra	Cinnamomum tamala	Lauraceae	Leaves	1/8 part

Table 3: Contents of Arogyavardhini vati :

S.No	Drug	Latinname / English name	Family	Part used	Ratio
1.	Shuddha Parada	Hydrargyrum /Mercury	-	-	1 Parts
2.	ShuddhaGandhaka	Sulphur	-	-	1 Parts
3.	Loha bhasma	Ferrum/Iron	-	-	1 Parts
4.	Abhraka bhasma	Mica	-	-	1 Parts
5.	Tamra bhasma	Cuprum/Copper	-	-	1 Parts
6.	Triphala churna		-	Fruit	2 Parts
	Amalaki	Emblica officinalis Linn.	Euphorbiaceae	Fruit
	Haritaki	Terminalia chebula Retz.	Combretaceae	Fruit
	Bibhitai	Terminalia bellirica Roxb.	Combretaceae	Fruit
7.	Shuddha Shilajatu	Asphaltum punjabinum	-	Resin	3 Parts
8.	Shuddha guggulu	Commiphora mukul	Burseraceae	Oleo gum resin	4 Parts
9.	Chitraka mula	Plumbago Zeylanica	Plumbaginaceae	Root	4 Parts
10.	Katuki churna	Picrorhiza Kurroa.	Scrophulariaceae	Root	18 Parts
11.	Nimba patra	Azadirachta indica	Meliaceae	Leaves	Appropriate quantity

Study sample:

The woman affected with PCOS with age limit of 18 to 40 years attending the outpatient and inpatient unit of department of Prasuti tantra and stree roga of National Institute of Ayurveda, Jaipur. Simple Random sampling was followed in the study. Selected subjects were randomly divided into two Groups, Group A and Group B by using Table of Random Number.

Study Settings:

Study was started on January 2015 and completed by June 2016.

Ethical clearance and CTRI registration:

The Institutional Ethical Committee of the National Institute of Ayurveda, Jaipur approved the study (Ref. No. F10 (5)/EC/2014/7225 dated 07/11/2014). This study had also been registered in CTRI (Clinical Trial Registry-India) and their registration no.is CTRI/2017/10/00994. An informed written consent was taken from each patient willing to participate before the commencement of the trial. The patients were free to withdraw their name from the study at any time without giving any reason.

Inclusion criteria of patient:

Patients aged between 18-40years, fulfilling at least 2 of following 3 criteria:

(Rotterdam revised criteria for PCOD, 2003)⁹

1. Oligomenorrhoea, and / or Anovulation

2. Hyperandrogenism (clinical and/or bio-chemical)

3. PCO- diagnosed by USG

Exclusion criteria of patient

1. Patients having any other disease causing oligomenorrhoea and anovulation excluding PCOD on above criteria.

2. Any organic lesions of reproductive tract like TB, carcinoma and congenital deformities or any other pelvic pathology.

3. Patients suffering from hyperprolactinemia, adrenal hyperplasia, severe insulin resistance, androgen secreting neoplasm, thyroid abnormalities, Cushing’s syndrome, cardiac diseases are excluded.

4. Current or previous (within last 3 months) use of OC Pills, Gluco-corticoids, anti-androgens, ovulation induction agents, anti diabetic, anti-obesity drugs, or other hormonal drug.

Intervention:

Table 4: Intervention

Group	Drug	Form	Dose	Route and Time of Administration	Duration
A	Pathadi kwatha	Decoction	20 gm bid in form of 80ml kwatha	Route: Oral Time: Apana Kala (twice daily morning and evening before food)	Three month
	Arogyavardhini Vati	Tablet	2tab(250mg each)
B	Kanchanaradi kwatha	Decoction	20 gm bid in form of 80ml kwatha	Route: Oral Time: Apana Kala (twice daily morning and evening before food)	Three month
	Arogyavardhini Vati	Tablet	2tab (250mg each)

Criteria for assessment:

Both subjective and objective criteria were implemented to find out the efficacy of trial drug as follows:

Subjective parameters:

Percentage improvement in cardinal clinical features of menstrual irregularities, duration, interval, pain and associated features like Acne, Hirsutism, Psycological symptoms etc To assess the effect of therapy, a dully prepared scoring system was composed.

Scoring pattern for sign and symptoms:

Gradation for Acne, Hirsutism (Ferryman Galmman scoring), Alopecia.

Assessment criteria of overall effect of therapy:

No change Less than 25% changes in the sign and symptoms, Mild Improvement 26-50% relief in the signs and symptoms, Moderate Improvement 51-75% relief in the signs and symptoms, Marked Improvement 76-99% relief in the signs and symptoms, Complete Remission 100% relief in the signs and symptoms.

Follow up:

After completion of course patients were advised to report for follow up study, which was carried out for 1 month. During the follow up study, further recurrence in the signs and symptoms were recorded.

Statistical Estimation of results:

The obtained data was analyzed with Graph pad insta software by Wilcoxson signed rank test for subjective parameter and paired and unpaired student ‘t’ test for assessment of Objective parameter. The level of ‘P’ between 0.05 to 0.01, and P<0.001 was considered as statistically significant and highly significant respectively. The level of significance was noted and interpreted accordingly. If the calculated ‘t’ value was more than 0.05 (P>0.05) results were taken as insignificant. Significant P < 0.05, Highly Significant P < 0.01 and 0.001

RESULTS:

Figure 1: Distribution according to menstrual abnormality (Intermenstrual period) in 110 patients of PCOD (DJBV).

Figure 2: Distribution according to menstrual abnormality (Days of menses) in 110 patients of PCOD (DJBV).

Table -3: Distribution according to Pradhana Vedana (Chief Complains) in 110 patients of PCOD (DJBV)

Table -4: Distribution according to Pradhana Vedana (Chief Complains) in 110 patients of PCOD (DJBV)

Table-5: Ferriman and Gallwey score wise distribution in 110 patients of PCOD (DJBV)

Table-6: Distribution according to findings of hormonal analysis in 100 Patients of PCOD (DJBV).

Table-7: Distribution according to findings of harmonal analysis in 110 Patients of PCOD (DJBV).

Table-8: Comparative effect of Pathadi kwatha and Kanchanar kwatha on acne.

Table-9: Comparative effect of Pathadi kwatha and Kanchanar kwatha on hirsutism

Table-10: Comparative effect of Pathadi kwatha and Kanchanar kwatha on Alopecia.

Table-11: Comparative effect of Pathadi kwatha and Kanchanar kwatha on Acanthosis nigricans.

DISCUSSION:

Hyperandrogenesism feature of PCOS disturb female physical appearance as well as major cause of psychological disturbance.

a. Seborrhagia and acne- Acharya susruta stated that due to vitiation of bhrajak pitta and vyan vayu along with kapha and rakta acne formation occur¹⁰

b. Hirsutism- When pitta aggravation at the level of bhrajaka pitta which is located in skin responsible for hirsutism or when 5 alfa reductase activity increase in skin which convert testosterone to more active metabolite dehydrotestosterone hirsutism occur. Androgenic alopecia- Female androgenic alopecia starts at the crown and is initiated as widening of the hair parting in the middle, seen in approximately 8% of women with PCOS.

c. Vitiated vata along with bhrajak pitta causing hairfall of the scalp after this kapha along with rakta causes closure of the papilla of hair follicle so that no new growth occur and lead to khalitya (alopecia)

Blackening of skin and Acanthosis nigricans:

Bhrajaka pitta is responsible for varna of skin. Pitta ksaya vridhi result in hypo or hyperpigmentation of skin. When vayu and kapha vitiated along with pitta result in shayava aruna varna and sukla varna of skin. Also, pitta vitiated rakta dhatu result in vaikrat varna. In PCOS patient skin become thickened, pigmented, velvety, most often found in vulva and may be present on the axilla, on the nape of the neck, below the breast, and on the inner thigh. It is acanthosis nigricans and considered as marker of insulin resistance in hirsute women¹¹.

About acne and hirsutism highly significant improvement was observed in both groups but group A Pathadi Kwatha showed better percentage of relief and Mean difference in acne i.e 48.84% and 0.73 when compared with the Kanchanaradi Kwatha treated group i.e. 44.83% and 0.68. However group A showed slight better result due to Raktshodhak and Kusthaghana, properties of Pathadi kwatha also Tikta rasa of Arogyavardhini vati which is common in both the groups stimulate function of liver and increases SHBG level and decreases free androgen level control acne.

Considering the relief in Acanthosis nigricans was (p=0.125) in Pathadi Kwatha treated group, while (p=0.5) in kanchanaradi Kwatha group which was statistically not significant in both the groups. But Group A showed slight better results. A study concluded the antidiabetic action of Zingiber officinale and its active principle 6-gingerol appears to involve 5-HT receptors, causing release of insulin and improvement of insulin sensitivity¹² thus it treat Acanthosis nigricans.

Both the groups had statistically highly significant results on reduction of serum LH:FSH ratio while Reduction of FBS:INSULIN ratio was statistically not significant in both the group. Reduction of S. FBS and FAI Score level was significant in Group A whereas not significant changes were observed in Group B. Disturbance in the functions of dhatwagni leads to various metabolic changes in females; hyperandrogenism is one of them which cause changes in normal hormonal function. Due to the deepan, pachan, ushna, teekshna and srotoshodhak property of both the trial drugs enhances the biofire and correct the hyperandrogenism. However group A showed more significant result i.e S. SHBG and s. Progesteron but group B also corrects some of the parameters of hormonal analysis.

CONCLUSION:

The dermatologic manifestations of PCOS play a significant role in diagnosis and constitute a substantial portion of the symptoms experienced by women with this syndrome. The trial drugs Pathadi kwatha and Arogyavardhini rasa is more effective than Kanchanaradi kwatha and Arogyavardhini rasa in reducing dermatological manifestation of PCOS (Dhatvagnimandya Janya Beejagranthi Vikara).

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11. Jonathan s. Berek Novaks gynaecology 12^th edition1996 williams and wikins Chapter 25 endocrine disorders pg 839

12. Sanjay, Kadnur V, Goyal, Ramesh K 10-Aug-2015, Gujarat University Completed Date: 31/12/2005 http://hdl.handle.net/ 10603/46222 Department of Pharmacology

Received on 10.12.2019 Modified on 18.01.2020

Accepted on 10.02.2020      ©Asian Pharma Press All Right Reserved

Asian J. Pharm. Res. 2020; 10(1):17-22.

DOI: 10.5958/2231-5691.2020.00004.0