Reprinted from     The Medicine & Surgery Vol XXiI No. 6 June-1982

"Leptaden" A Nonhormonal Ayurvedic Drug, For Deficient Lactation In Mothers of An Urban Community

(A Double-blind Clinical Trial)

By

Bhupendra C. Patel, M.D.. D.G.O., ** Manoj V. Parikh, M.D., D.G.O., ** (Mrs.) Leela B. Patel, M.D. D.G.O,,

* Hony. Professor of Obstetrics & Gynaecology

Senior Registrar Dept. of Obstetrics & Gynaecology, S.S. G. Hospital & Baroda Medical College, Baroda.

** Consultant Obstetrician & Gynaecologist,Prabhooli, Baroda

 

Introduction

Deficient lactation and some­times complete absence of lactation are said to be more common in mothers of an urban population than those livina in rural areas. Breast milk, is the best for the baby, being the natural nutrition for the child. Even in the Western countries and by WHO, there is a regular campaign now going on: "Breast milk is the best" and advising all the mothers to adopt "Back to the Breast Feeding". Besides, artificial milk feeding is accompanied with certain hazards, the most common of them being diarrhoea which has a high mortality risk during the first year of child's life.

Leptaden, an Ayurvedic nonhor­monal drug was selected for this study, because many papers have appeared regarding its usefulness as a galactogogue and on the safety of this herbal preparation.

Leptaden

Each tablet of Leptaden contains : Kamboji (Breynia patens) : 150 mg Jeevanti (Leptadenia reticulata) 150mg

Leptaden is described to have lactogenic, galactopoietic and galac­tokinetic properties; safe drug without side effects to the mother or the breast fed child; in cases with a history of lactational difficulties during the previous child birth, Leptaden helps in correcting the problem during the present child birth.

 

Materials & Methods

The clinical trial was conducted during 1980-81 on patients in the Dept. ot Obst. & Gynec., S.S.G. Hospital, Baroda. Half cases from the private "Prabhooli" Maternity & Gynec. Hospital, Baroda were also included. When the number of cases reached 30, in each of X and Y groups, (a total of 60 cases) which was our target, analysis of the results were done.

We were supplied with two sets of identical looking capsules, one set marked as X capsules and the other set marked as Y capsules. We were informed that one set of capsules contained Leptaden in powder form (one capsule containing Leptaden equivalent to one Leptaden tablet) and the other set contained a placebo powder. Those who were given X capsules were called the X Group and those who received the Y capsules were called the Y Group After the Double Blind Clinical trial was over, we asked for the identity of X and Y capsules, when it was revealed to us which set contained Laptaden and which set contained the placebo.

The recordings of breast milk secretion of two days were taken before starting X or Y capsules and was called `Before Therapy' data. Then X or Y capsules were regularly given for 7 days. After that daily recordings of breast milk secretion was taken for 5 days. This was called the `After Therapy' data. The means of `Before Therapy' and `After Therapy' data were taken for assessment of results and compara­tive study between X & Y Groups.

The baby was weighed before and after breast feeding, and the difference in weight was taken as the amount of breast milk. secreted. This was done for all the breast feedings in a day for a 12 hour day time period. Baby was breast fed every three hours. I t was not possible for us to have a 24 hour recordings because of practical difficulties.

 

Past History of Lactation

Food Habits, Etc.

Among 28 cases of multi para, 14 cases of X Group and 10 cases of Y Group, a total 24 cases, had history of deficient lactation for the previous child. All our cases were from the urban community, belong- ing to middle and higher soc economic groups. All were pure vegetarians except two patients. Nipple examination showed that 2 cases had retracted nipples and they were advised to use the shield.

Gestation
There was full term delivery in 50 cases (83.3%) & 10 cases (16.7%). In this series, series, we had no case of retarded growth. All cases were of live birth. (Table III).

Mode of Delivery
In our present series, 40 cases had normal delivery, 10 (66.6%) cases (16.7%) had delivery by Caesarian section, and 10 cases (16.7%) were delivered either by forceps or by vacuum method. (Table IV)

Birth Weight

Only 10 babies (16.7%) had low birth weight of less than 2500 gms.; 32 babies (53,3%) had birth weight between 2500-3000 gms,; and 18 babies (30,0%) had birth weight of more than 3000 gms. (Table V).

Initiation of Treatment to the Mother After Delivery : X or Y Capsules

X or Y capsules were given to the mother in a dose of 2 capsules , three times a day for 7 days. Majo­rity of cases (32) received treatment within 5 days of delivery (Table VI)

 

Age Groups
Among 60 cases, the age group of 21 - 30 yrs. was the largest with 52 cases (86.7%) (Table 1)

Table I : Age Groups

	X Group	Y Group	Total	%
20 yrs and below 21-30yrs 31 yrs & over	2 26 2	4 26 0	6 52 2	10& 86.7% 3.3%
Total	30	30	60	100.0%

Parity
Among 60 caes under study, 32 cases(53.3%) were of primi para & 25 cases(46.7%) were of multi para.

Table II Parity

Parity	X Group	Y Group	Total	%
Primi para Multi para	l2 18	20 10	32 28	53.3% 46.7%
Total	30	30	60	100.0%
Table IlI : Gestation.
Gestation	X Group	Y Group	To" al
Full term Pre - term	26 4	24 6	50 10	83.3% 16.7%
Total	30	30	60	100.0%

Table 1V : Mode of delivery intra-uterine

Delivery	X Group	Y Group	Total	%
Normal delivery	20	20	40	66.6%
Caesarian section	4	6	10	16.7%
Forceps/Vacuum method	6	4	10	16.7%
Total	30	30	60	100

Table V : Birth Weight.

 

 

Birth Weight	X Group	Y Group	Total	%
Less than 2500 gms	4	6	10	16.7%
2500-3000-gms	14	18	32	53.3%
Greater than 3000gms	12	6	18	30%
Total	30	30	60	100%

 

Table VI : Initiation of treatment to the mother after delivery.

Initiation	X Group	Y Group	Total	%
Within 5 days	18	14	32	53.3%
6 -10 days	10	10	20	33.4%
11-15days	2	6	8	13.3%
Total	30	30	60	100%

 

 

Table VlI : Showing results of breast milk secreted before and after therapy with X capsules.

Before giving X capsules	Total cases	After giving  X capsules
		21-60 gms		61-120gms		121-180
00-20 gms.	14	2	14.3%	9	64.3%	3      21.4%
21-60 gms.	16	2	12.50/,	6	37.5 %	8         50.0%
61-120gms.	-	-			­
121-180gms.	- ....	-
Total	30	4	13.3%	15	50.0%	11      36.7%

 

Table VIII . Breast milk capsules.

Before giving Y capsules	Total cases	Increase in Breast milk after giving Y capsules
		21-60 gms		61-120 gms	121-180 gms
00-20 gms.	13	11	84.6%	2     15.4%	0	-
21-60 gms.	17	11	64.7%	4     23.5%	2	11.8%
61-120 gms.				-
121-180 gms.		-
Total	30	22	73.3%	6      20%	2	6.7%

 

Table 1X : Therapeutic effects of Leptaden in Double-blind clinical trial.

Result	Leptaden	%	Placebo	0 io
Very good	11	36.7%	2	6.7%
Satisfactory	15	50.0%		20.0%
Poor	4	13.3%	22	73.3%
Total	30	100.0%	30	1000%

 

Weight of Breast Milk Sec­reted Before Therapy and After Therapy With X or Y Capsules

Weight of breast milk secreted is calculated by weighing the baby before breast feeding and after breast feeding and the difference in weight was taken as the weight of breast milk secreted, as already mentioned.

Breast Milk Response with X Capsules

With X capsules to the mother, in 11 cases (36.7%), the maximum breast milk secretion of 121-180 gms was seen. In 15 cases (50X%), the breast milk secretion was 61-120 gms. Only in 4 cases (13.3%), the breast milk secretion was poor, as it showed practically no difference before and after therapy with X capsules. (Table VII).

 

Breast Milk Response With Y Capsules

With Y capsules to the mother, in 2 cases only (6.7%) there was maximum increase of 121-180 gms; 6 cases (20.0%) had moderate incr­ease (61-120 gms.) and 1n the majo­rity of 2L cases (13.3%), there was practically no difference in breast milk Secretion before and after giv­ing Y capsules (Table VIII).

 

Breast Milk Secretion: Com­parison Between Leptaden And Placebo

With Leptaden treatment, lacta­tion improved satisfactorily in 86.7% while with the placebo, the increase was only by 26.7% The response was poor only in 4 cases (13.3%) with Leptaden therapy, while it was poor in 22 cases (73.3°/Q) with the placebo. This Double-blind clinical trial has shown the efficacy of Lep­taden as a good galactagogue in deficient lactation in mothers of an urban community in whom this is a common complaint. (Table IX).

 

Side Effects or Toxic Effects

There were no side effects or toxic effects with Leptaden or the placebo. Though the child is breast fed by the mother taking Leptaden, no side effects were seen in the child also, showing the safety of the drug to mother and child.

 

Conclusions

1 Double blind clinical trial has shown that Leptaden is a good galactagogue.

2 Safe to the mother and also to the child who is breast fed by mother under Leptaden therapy.

 

Acknowledgement

We thank Alarsin Pharmaceu­ticals, Bombay 400 023 for their cooperation.

 

References

1 Bhandari, N R. and Soni, S.L. (1979) : A Controlled trial on Leptaden in weight gain of infants and as a galactagogue in Lacta­tion cases - The Indian Pract. 32;4, p.229-240, April 1979.

2 Deshpande Malati and Manju Asher (1962) : Mystery of Lacta­tion - A clinical Study on an Indian Drug Antiseptic, 59;11, Nov. 1962

3 Gokhale Malati (1965) : A Herbal Drug that stimulates Lactation - The Indian Practitioner, 18:12, Dec. 1965.

4 Habla Akhtar and Sitaratna (1972) Leptaden - A       clinical trial as a Galactagogue - Antiseptic, 69;5, May 1972.

5 Jyoti Kothari and Meena Kothari (1972) : Breast Feeding & Lep­taden -48th All India Med. Conf. Ahmedabad, Dec. 1972.

6 Kasturi Lal, Singh Bhupinder; Gupta, Yudhister Vir, Singh, Bhupinder; Tiku, C.N.; Jamwal, D.S. (1978) A Controlled trial of Leptaden in lactational failure & an experimental study in lactating

rats - 22nd All India Obst. & Gynec. Congress, Indore, 28-30 Dec. 78 & Indian Pract:. XXXIII (10), pp : 557 - 564, Oct. 1980.

7 Kusum Gupta & Naval Kishore (1966) : Lactation - A Clinical Trial with      Leptaden, a Herbal Drug - The Antiseptic,                   63; 10, Oct. 1966.

8 Mrs. Purandare, Manda C., Purandare, B.N. (1977) Study of the composition of Breast Milk and effect of Leptaden on      
    the quality of Breast Milk -- XV International Congress of Paedia­trics, New Delhi 23 - 29, Oct. 1977.

9 Padma Rao and Devi H.I. (1977) Effect of Leptaden on Lactation (A controlled clinical study) - Antiseptic 74;7, 337-40, 1977.

10 Trivedi S.B. (1956): Can Lacta­tion be stimulated? - Indian

Practitioner, 9:2, Feb. 1956.

Pharmacological Trials

1 Agarwal S.L., Deshmankar B,S , Verma S C.L,, and Saxena S P. (1960) : Studies of Leptadenia Raticulata - Pharmacological Actions of Aqueous extract (In­dependent Study from Dept, of Pharmacology) - Indian Journal of Med. Research, 457-464, July 1960.

2 Sharma S.C. (1970): Leptaden on milk yield in the Lactating Rats - Paper before : 19th Indian Veterinary Conference, Ranchi, 1970.

3 Shrivastava P.N., Shrivastava D.N. and Ahmed A.H. (1974): Pharmacological studies on Indi­genous drugs Leptadenia Reticu­lata and Byernia Patens -Indian Veterinary Journal, 51, Juiy - August, 1974.