6.  BRIEF RESUME OF THE INTENDED WORK

6.1  NEED FOR STUDY

 

Menstruation is one of the physiological process seen in reproductive phase, which denotes the healthy state of female reproductive system.In today’s fast moving competing world, women need to be multi-tasking,the process of menstruation will cause minimized disturbance in day to day activities,if this menstruation is associated with pain then it is still more annoying,this will again cause difficulty for a women to lead her daily activities and balance work and family,menstruation associated with pain is called as dysmenorrhea.

Dysmenorrhea is the most important cause of chronic pelvic pain and the disease burden of dysmenorrhea is estimated to be greater than any other gynecological morbidity, in women of reproductive period . The epidemiology of primary dysmenorrhea is 25 to 90% among women and adolescents respectively.¹ Studies from India reported the prevalence range between 50% to 87.8 % of women of reproductive age.²

Dysmenorrhea is mainly of two types primary dysmenorrhea and secondary dysmenorrhea, The primary dysmenorrhea is one where there is no identifiable pelvic pathology and secondary dysmenorrhea is normally considered to be menstruation with pain in presence of pelvic pathology.³

The clinical feature of the primary dysmenorrhea includes recurrent cramp suprapubic pain which may radiate to back and thighs occurring just before or during menses and lasting two or three days, pain may radiate into the lower back and thighs and may be associated with nausea, fatigue, bloating and general malaise, vomiting and diarrhea.³

The dysmenorrhea can be correlated withUdavartini Yonivyapad in Ayurveda. Udavartini Yonivyapad is characterized asVedana Yukta Artava Munchan a complaint with spasms andcontraction. The Vedana Yukta Artava Munchan, this condition can be easily identified with the clinical entity of Primary dysmenorrhea in modern gynecological parlance. Primary dysmenorrhea is menstrual pain without pelvic pathology which incapacitate day today activities of a women.⁴

In AyurvedaApana-Vayu has been given prime importance in Stree rogaas it does the Arthava Niskaraman in Stree.Due to the causative factors like Vata kara Ahara Vihara, the Apana Vayu get aggravated and causesPratiloma Gati of Apana Vayu,which leads topain,So

painful menstruation is considered to beApana-vayu dusti. Charaka first described Udavarta in Vataja Nanatmaja diseases.⁵In this Rajas is pushed in upward direction by the aggravated Apana Vayu due to obstruction in its normal flow and causes pain during menstruation.⁶

As Vata is the causative factor for Udavartini Yonivyapad, so it should be treated first. Hence Saptasaram Ghana Vati is one such formulation explained in Sahasrayogawhich act as Yoni Shoola,⁷along with this almost the contents are having Katu, Tikta, kashaya Rasa Yukta,Ushana Veerya, Madhuraand Katu Vipaka, Vata Kapha Shamaka, Shoolaprashamana which will be useful in treatingUdavartini Yonivyapad. Hence the Saptasaranghana vati is been taken for this study.

6.2  REVIEW OF LITERATURE

 

l  Nidana, Lakshana, Samprapti of Udavarta yonivyapad are explained in Charaka SamhitaChikitsaSthana,⁸Sushruta Samhita Uttara tantra,⁹ Astanga Hridaya Uttara tantra.¹⁰

l  Vataja Yonivyapad Chikitsa is been described in Charaka Samhita Chikitsasthana.¹¹

l  Saptasaram kashaya  is indicated as Yoni Shoolain Sahasrayoga.⁷

 

 

DRUG REVIEW – SAPTASARAM GHANA VATI

 

Table 01. Rasa Panchaka and Karma of the ingredients in Saptasaram Ghana Vati¹²

 

S.N	DRUG	LATIN NAME	PART USED	RASA	GUNA	VIRYA	VIPAKA	KARMA
1.	Varshabhu	Boerhaavia diffusa	Root	Madhura, Tikta, Kashaya.	Laghu, Ruksha	Ushna	Katu	Tridosha hara
2.	Bilwa	Aegle marmelous	Root	Kashaya, Tikta	Laghu, Ruksha	Ushna	Katu	Vata and kapha shamaka
3.	Khalva purana	Dolichos biflorus	Seed	Kashaya	Laghu, Ruksha, Tikshna	Ushna	Katu	Kapha Vata shamaka

4.	Urubu	Ricinus Communis	Root	Madhura, Katu, Kashaya	Laghu, Ruksha, Tikshna	Ushna	Madhura	Vata Kapha shamaka
5.	Sahachara	Barleria prionitis	Root	Tikta, Madhura	Laghu,	Ushna	Katu	Kapha Vata shamaka
6.	Shunthi	Zingiber officinale	Rhizome	Katu	Guru, Ruksha, Tikshna	Ushna	Madhura	Kapha Vata shamaka
7.	Agnimanta	Premna integrifolia	Root	Tikta, Katu, Kashaya Madhura	Ruksha, Laghu	Ushna	Katu	Kapha Vata shamaka

 

Table       02:       Showing       the       Rasa                 Panchakas&Doshaghnata   of            herbal drugsusedinthepreparationof Chandraprabha vati.^12,13

S.NO	DRUG	LATIN NAME	GUNA	RASA	VIPAK A	VEERY A	KARMA
1	Karpura	Cinnamo mumcamp hora	Laghu,ruksha	Tikta,katu, Madhura	Katu	Sheeta	Kaphahara
2	Vacha	Acoruscata mus	Laghu,Tikshna	Katu,Tikta	Katu	Ushna	Kapha- Vatahara
3	Musta	Cyperusrot undus	Laghu,Ruksha	Tikta	Katu	Sheeta	Kapha- Pittahara
4	Bhunimba	Swertiachirat a	Laghu, Ruksha	Tikta	Katu	Sheeta	Kapha- Pittahara
5	Guduchi	Tinosporac ordifolia	Guru,Snigdha	Tikta,Kashaya	Madhura	Ushna	Tridosha hara
6	Devadaru	Cedrusdeod ara	Ruksha,Laghu	Tikta,Katu,Ka shaya	Katu	Ushna	Kapha- Vatahar a

7	Haridra	Curcumalong a	Ruksha, Laghu	Tikta, Katu	Katu	Ushna	Kapha- Vatahar a
8	Ativisha	Aconitum Herophyllu m	Laghu,Ruksha	Katu,Tikta	Katu	Ushna	Tridosha hara
9	Daruharidra	Berberisaris tata	Laghu,Ruksha	Tikta,Kashaya	Katu	Ushna	Kapha- Pittahara
10	Pippalimula	Piperlongum	Laghu, Ruksha	Katu	Katu	Ushna	Kapha- Vatahar a
11	Chitraka	Plumbagoz eylanica	Laghu,Ruksha, Tikshna	Katu	Katu	Ushna	Vata- Kaphaha ra
12	Dhanyaka	Coriandrum sativum	Laghu,Snigdha	Kashaya,Tikta	Madhura	Ushna	Tridosha hara
13	Haritaki	Terminaliac hebula	Laghu,Ruksha	Pancharasa(e xcept lavana)	Madhura	Ushna	Tridosha hara
14	Bibhitaki	Terminaliab ellerica	Ruksha,Laghu	Kashaya	Madhura	Ushna	Kapha- Pittahara
15	Amalaki	Emblicaoffici nalis	Guru	Pancharasa (exceptlavana)	Madhura	Sheeta	Tridosha hara
16	Chavya	Piperchaba	Laghu,Ruksha	Katu	Katu	Ushna	Kapha- Vatahar a
17	Vidanga	Embeliaribe s	Laghu,Ruksha, Tikshna	Katu,Kashaya	Katu	Ushna	Vata- Kaphaha ra
18	Gajapippali	Scindaspus Officinalis	Laghu,Ruksha	Katu	-	-	Vata- Kapha Hara

19	Pippali	Piperlongu m	Laghu, snigdha ,	Katu	Madhura	Ushna (dry) Sheeta (wet)	Vata- Kaphaha ra
20	Maricha	Pipernigru m	Laghu,Tikshna	Katu	Katu	Ushna	Kapha- Vatahar a
21	Shunti	Zingiberoffi cinale	Guru,Ruksha, Tikshna	Katu	Madhura	Ushna	Vata- Kaphaha ra
22	Trivrt	Operculina turpethum	Laghu,ruksha, Tikshna	Tikta,Katu	Katu	Ushna	Kapha- Pittahara
23	Danti	Baliosperm ummontanu m	Guru,Tikshna	Katu	Katu	Ushna	Kapha- Vatahar a
24	Patraka	Cinnamom umtamala	Tikshna,Laghu ,Pichila	Madhura ,Katu	Katu	Ushna	Kapha- Vatahar a
25	Twak	Cinnamomum Zeylanica	Laghu,Ruksha, Tikshna	Katu,Tikta, Madhura	Katu	Ushna	Vata- Pittahara
26	Ela	Elettariacor damomum	Laghu,Ruksha	Katu,Madhura	Katu	Sheeta	Kapha- vatahara
27	Vamsha(V.lo chana)	Bambusa Arundinace ae	Laghu,Ruksha	Madhur,kasha ya	Madhura	Sheeta	Kapha- Pittahara
28	Guggulu	Commiphora mukul	Laghu,Ruksha, Vishada,Suksh ma , Sara(Old)   Snigdha,Pichil a(New)	Tikta,katu	Katu	Ushna	Tridosha hara

29

Sharkara(Iksh u)

Saccharum officinarum

Madhura

Madhura

Sheeta

Vata- Pittahara

 

Table

2.1 :ShowingthedetailsofLavanas(Lavanavarga)usedinpreparationofCh andraprabha Vati.¹⁴

S.N	Sanskrit name	English name	Latin name	Rasa panchaka	Karma
1	Saindhava	Rocksalt	Sodii	Guna-	Tridosha
	Lavana		Chloridum	Laghu,Snigdha,	shamaka
				Sukshma
				Rasa-
				Lavana
				Vipaka-Katu
				Virya-Sheeta
2	Sauvarchala	Sochalsalt	Unaqua	Guna-Laghu,	Vatashamaka
	Lavana		Sodium	Vishoda,Sukshma,
			Chloride	Snigdha
				Rasa-Madhura
				Vipaka-Madhura
				Virya-Ushna
3	Bidalavana	Amonium	Amonium	Guna-Laghu,	Vatashamaka
		Chloride	Chloride	Sukshma,Tikshna
				Rasa-Lavana
				Vipaka-Madhura
				Virya-Ushna

Table

2.2 :ShowingthedetailsofmineraldrugsusedinthepreparationofChandrapr abhaVati.¹⁵

S.N	SANSKRI T NAME	CHEMICAL NAME	CHEMICAL FORMULA	RASA PANCHAKA	KARMA
1	Makshika bhasma	Copperpyrite s/Chalcopyri tes	Cu2Fe2S4	Laghu guna,Madhura, amla rasa,Katu vipaka, Sheetaveerya	Tridoshashama ka
2	Lohabhasma	Iron	Fe2O3	Tikta rasa, Madhuravipaka, Sheetaveerya	Kapha Vatashmaka
3	Shuddha Shilajatu	Blackbitumen	-	Tikta, Katu rasa,Katuvipaka,Ushn a Veerya	Kaphashamaka

 

 

Table2.3:ShowingthedetailsofKsharasusedinthepreparationofChandraprabhaV ati.¹⁶

S.N	SANSKRIT NAME	ENGLISH NAME	SYNONYMS	RASA PANCHAKA	KARMA
1	Sarja	Obtainedfrom	Svarjikakshara,	Laghu,Ruksha,Ushna,	-
	Kshara	Ushtrapriya	Sarjika,	Tikshna
		(RT)	Sukhorchika
2	Yava	Mixtureof	Yavapatya,	Laghu,Snigdha,Sara	Kapha-Vata
	Kshara	potassiumsalts	Yavaja,	Guna	shamaka
		(Obtainedfrom		Katurasa,Katuvipaka,
		husk& grass of		Ushnaveerya
		yava/barley)

PREVIOUS WORK DONE

 

Ø  Udayakala P, Clinical management of Udavartini Yonivyapad with Sukumara ghrita

w.s.r. to primary dysmenorrhea. Prasutitantra Stri Roga, Shri Dharmasthala manjunatheshwara college of Ayurveda and Hospital, Hassan, 2014.

Ø  Nanda K. A clinical study to evaluate the effect of Erandamooladi Niruha Vasti in Udavartini Yonivyapad w.s.r. to Primary dysmenorrhea. Prasutitantra and Stri Roga, Shri Dharmasthala manjunatheshwara college of Ayurveda and Hospital, Hassan, 2014.

Ø  Niveditha S. A clinical study to evaluate combined effect of Chandraprabha Vati with Haritaki Churna on Udavartini Yonivyapad w.s.r to Spasmodic dysmenorrhea, Prasuti Tantra and Stri Roga, Shri Jagadguru Gavisiddheshwar Ayurveda Medical college and Research Centre, Koppal, 2015.

Ø  Rachana A S, A clinical study to evaluate the efficacy of Higwadi Vati in Udavartini Yonivyapad w.s.r to Primary dysmenorrhea, Prasuti Tantra and Stri Roga, Alva’s Ayurvedic Medical College, Moodbidri 2015.

Ø  Rajalaxmi Ravindrum, Aclinical study to evaluate the efficacy of Tilvakadi Ghrit in Udavartini w.s.r to Primary dysmenorrhea, Prasuti Tantra and Stri Roga, Alva’s Ayurvedic Medical College, Moodbidri 2015

Ø  Rashmi verma, A Open label comparative clinical study to evaluate the Antispasmodic effect of Kumarika Vati and mefenamic acid in the management of Udavartini Yonivyapad (Spasmodic dysmenorrhea), Prasuti Tantra and Stri Roga, Shri Jagadguru Gavisiddheshwar Ayurveda Medical college and Research Centre, Koppal, 2021.

 

6.3  AIMS AND OBJECTIVE OF STUDY

 

·     To evaluate the efficacy of Saptasaramghana Vati in the management of Udavartini Yonivyapad (Primary dysmenorrhea) .

·     To compare the efficacy of Saptasaramghana Vati and Chandraprabha Vati in the management of (Primary Dysmenorrhea).

7.  MATERIAL AND METHODS

 

Hypothesis

 

H0: There is no statistical significance of Saptasaram Ghana Vati in the Management

Udavartini Yoni Vyapad (Primary dysmenorrhea)

H1:There is statistical significance of Saptasaram Ghana Vati in the Management

Udavartini Yoni Vyapad (Primary dysmenorrhea)

H2: There is statistical significance ofChandraprabha Vatiin the management of

Udavartini Yoni Vyapad (Primary dysmenorrhea)

H3: Both Saptasaramghana vati and Chandraprabha Vati have equivalent statistical significance the management of Udavartini Yoni Vyapad (Primary dysmenorrhea)

7.1  SOURCE OF DATA

 

A)  LITERARY SOURCE

 

All the Ayurvedic, Modern literature and contemporary texts including the authenticated web journals about the disease and treatment will be reviewed and document for the intended study.

B)  SAMPLE SOURCE

 

Patients attending OPD of the Dept of Prasooti Tantra&Streeroga of S.J.G.A.M. College & Research center, Koppal and other referral source will be taken for the study.

C)  DRUG SOURCE

 

The drugs required for the study will be procured from an authenticated pharmacy under the supervision of Dept. of Dravya Guna and Rasashastra and Bhaishajya Kalpana of S.J.G.A.M. College and Research center Koppal.

7.2  METHODS OF COLLECTIONS OF DATA

 

1)  STUDY DESIGN

A controlled clinical trial

 

2)  SAMPLE SIZE

This is a controlled clinical study with 40 patients fulfilling the inclusion criteria will be selected and randomly allocated into two equal groups containing each 20 patients: Group A (trail group) and Group B (control group).

A.    INTERVENTIONS

Group A is a Trail group of 20 patients who will be treated with the Saptasaram Ghana Vati in the dosage of 500mg BD before food for 5days, 3days before expected date of menses and 2days after the start of menses, for 3 consecutive cycles.

Group B is a control group of 20 patients who will be treated with the Chandraprabha Vati in the dosage of 500mg BD before food for 5 days, 3days before expected date of menses and 2days after the start of menses, for 3 consecutive cycles.

Study Duration - 6cycles

Treatment period - 3 cycles

Follow up –3rdday of next 3 consecutive cycle after treatment.

 

B.METHOD OF PREPARATION OF SAPTASARAM GHANA VATI

 

Ingredients (Kalka Dravyas) numbered 1 to 7 in the composition will be taken dried and powdered and will be passed through sieve number 44.The powdered ingredients will be transfered into a stainless steel vessel and sufficient quantity of water will be added to soak it overnight. On the following day water will be again added to make it 16 parts of Kalka Dravya. The above ingredients will be boiled on mild fire by keeping lid open till the total quantity is reduced to 1/8^th. Later the Kwatha will be filtered through a muslin cloth. This filtrate will be further boiled on mild fire to obtain a semisolid content called Ghana. It will be dried in shade and will be rolled into pills called Ghana Vati.¹⁷

3)  SELECTION CRITERIA

 

A.    DIAGNOSTIC CRITERIA

·       Patients having primary dysmenorrhea.

·       Patients between ages of 15 to 35.

·       Patients having regular menstrual cycles.

 

B.    INCLUSION CRITERIA

 

·       Patients suffering from primary dysmenorrhea

·       Both married and unmarried women age group between 15-35 years

·       Patients suffering for more than 3 consecutive cycle

·       Patients with regular menstrual cycle.

C.    EXCLUSION CRITERIA

 

·       Patient having secondary dysmenorrhea

·       Patient with abnormal uterine bleeding

·       Patient with dysfunctional uterine bleeding

·       Patient with any systemic illness

·       Structural pelvic pathology

·       Patient with IUCD, Pelvic organ infection, uterine polyps, endometriosis, fibroiduterus.

·       Congenital anomalies of female reproductive system

·       Lactating mother

 

D.    Assessment Criteria

·       Interval between the cycles

·       Associated complaints

·       Pain Intensity

·     Pain Duration

·       Site of pain

Assessment of Results

Subjective and objective parameters will be compared and statistically analyzed using the readings of before and after the treatment.

 

SUBJECTIVE PARAMETERS

 

·       Interval between the cycles

·       Associated complaints –Nausea Vomiting

Headache

OBJECTIVE PARAMETERS

 

·       Pain Intensity

·       Pain Duration

·       Site of pain

GRADINGS

Interval between the cycles

 

Interval between the cycles	Grade
28-30 Days	0
31-34Days	1

 

 

Associated complaints

 

Changes in associated complaints	Grade
Associated complaints absent	0
Associated complaints present	1

 

 

Pain intensity based on Visual pain analogue scalein analogue scale

 

Pain intensity	Grade
No pain	0
Mild (1 - 3)	1
Moderate (4 - 7)	2
Severe (8 - 10)	3

 

Pain duration

 

Pain duration	Grade
No pain	0
Previous day and 1st day	1
2nd and 3rd day	2
4th day	3

 

Site of pain

 

Site of pain	Grade
Pain in Supra-Pubic region	1
Pain in Supra-Pubic region & lumber region	2
Pain in Supra-Pubic Lumber & Thigh region	3

STATISTICAL ANALYSIS

 

A detailed proforma will be prepared and assessment is done on graduations given for the Parameters. The data will be analysed using Wilcoxon Signed Rank test and Mann- Whitney U test.

Investigations:

 

·       Ultrasonography of abdomen and pelvis

·       Hb gm%

 

7.3  Does the study require any investigation or interventions to be done on patients or other humans or animals? If so please describe

Yes the study will be conducted clinically on humans. No animal experimentation will be carried out.

7.4  Has ethical clearance been obtained from your institution in case?

Yes, obtained and enclosed.

 

 

List of References

1.       https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2853792/

2.       Nahal Habibi Msc, Mary Soo, Lee Hung PhD, Wan Ying Gan Phd, Rejaji Zulida MD, Sayyed Morteza Safavi Phd, Prevalence of Primary dysmenorrhea And Factors Associated with Its Intensity Among Undergraduate Student, A Cross Sectional Study, https//doi.org/10.1016/j.pmn.2015.07.001.

3.       Hiralal Konar, D.C. Datta Text Book of Gynecology, Jaypee Brothers Medical Publishers, 6th Edition 2013, Page No.178.

4.       Shashikala karanth, S.R. Liya, Prevalence and Risk Factors for Dysmenorrhea Among Nursing Student and Its Impact on Their Quality of life, International Journal of Reproductive, Contraception, Obstetrics and Gynecology, July 2018 Page No. 2661-2667

5.       Agnivesha. Charaka Samhita sutrasthana 20/13, Chaukhambha Sanskrit Series Office, Varanasi, 2009. Page No. 113

6.       Agnivesha. Charakasamhita chikitsasthana 30/110-120, Chaukhambha Sanskrit Series Office, Varanasi, 2009, Page No. 635-645